Puros Demineralized Bone Matrix (DBM) with Reverse Phase Medium (RPM)

The Complete Bone Remodeling Triad

puros-with-rpm

Putty and Putty with Chips

Puros® Demineralized Bone Matrix with Reverse Phase Medium (DBM with RPM) Putty & Putty with Chips are unique bone graft substitutes composed of demineralized bone matrix in a reverse phase medium. Puros DBM with RPM products are designed to stimulate natural bone formation processes, in which mesenchymal cells differentiate into bone-forming cells. Because the reverse phase medium becomes more viscous at warm temperatures, it allows the allograft to be malleable at operating room temperatures, but causes the product to stiffen when placed in the operative site. Thus, the DBM is contained at the surgical site with minimal loss through irrigation and suction.

Variability in allograft tissue is always a concern as no two donors are alike, which is why Zimmer Biomet utilizes a highly regarded in-vivo test to confirm osteoinductive potential of every lot to ensure the ability to grow new bone. Additionally, all lots are tested for osteoinductive potential after sterilization.

**Puros RPM Putty with Chips contains (850 microns to 4mm) cortical bone chips.

Gel and Paste

Puros® Demineralized Bone Matrix with Reverse Phase Medium (DBM with RPM) Gel and Paste are unique bone graft substitutes composed of demineralized bone matrix in a reverse phase medium. Puros DBM with RPM products are designed to stimulate natural bone formation processes, in which mesenchymal cells differentiate into bone-forming cells. Because the reverse phase medium becomes more viscous at warm temperatures, it allows the allograft to be malleable at operating room temperatures, but causes the product to stiffen when placed in the operative site. Thus, the DBM is contained at the surgical site with minimal loss through irrigation and suction.

Variability in allograft tissue is always a concern as no two donors are alike, which is why Zimmer Biomet utilizes a highly regarded in-vivo test to confirm osteoinductive potential of every lot to ensure the ability to grow new bone. Additionally, all lots are tested for osteoinductive potential after sterilization.

*Puros RPM Paste contains added ground cancellous bone (<500 microns) to provide additional structural properties for bone growth.

Description

Puros DBM RPM Putty with Chips and Paste, Cancellous are a combination of human bone tissue that has been demineralized, and cancellous bone (from the same donor), mixed with poloxamer reverse phase medium and formulated into a putty or paste-like form.  As biological materials, some variations in the product should be expected, such as in appearance and in handling.  Puros DBM RPM is provided in a sterile, single patient use package.

Donor Eligibility: Donor eligibility (screening and testing) is performed in accordance with AATB Standards and FDA regulations.  Donor screening includes assessment of the medical and social history as well as physician assessment of the donor to assure that no conditions exist that may make the tissue unacceptable for transplantation.  Donor eligibility has been determined by an AlloSource® Medical Director.

Serological Testing: Communicable disease testing was performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493.  The testing was conducted using FDA licensed, approved, or cleared donor screening tests for cadaveric specimens where applicable.  The records of this testing are maintained at AlloSource at the address listed at the bottom of this document.  The following required testing was performed and found to be negative or non-reactive:

  • Antibody to Human Immunodeficiency Virus 1 & 2 (HIV 1 & 2)
  • Human Immunodeficiency Virus Type 1 (HIV NAT)
  • Antibody to Hepatitis C (HCV)
  • Hepatitis C Virus (HCV NAT)
  • Hepatitis B Core IgG/IgM Antibody (HBcAb)
  • Hepatitis B Surface Antigen (HBsAg)
  • Rapid Plasma Reagin or Serologic Test for Syphilis (RPR or STS)

Additional tests including, but not limited to, Human T-Cell Lymphotropic Virus Type I & II (HTLV I & II) may have been performed at the time of donor screening and were found to be acceptable for transplantation.  A list of additional communicable disease test(s) performed may be provided upon request.

Puros DBM RPM Putty and Gel are human bone tissue that has been demineralized, mixed with poloxamer reverse phase medium and formulated into a putty or gel-like form.  As a biological material, some variations in the product should be expected, such as in appearance and in handling.  Puros DBM RPM is provided in a sterile, single patient use package.

Donor Eligibility:  Donor eligibility (screening and testing) is performed in accordance with AATB Standards and FDA regulations.  Donor screening includes assessment of the medical and social history as well as physician assessment of the donor to assure that no conditions exist that may make the tissue unacceptable for transplantation.  Donor eligibility has been determined by an AlloSource® Medical Director.

Serological Testing:  Communicable disease testing was performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493.  The testing was conducted using FDA licensed, approved, or cleared donor screening tests for cadaveric specimens where applicable.  The records of this testing are maintained at AlloSource at the address listed at the bottom of this document. The following required testing was performed and found to be negative or non-reactive:

  • Antibody to Human Immunodeficiency Virus 1& 2 (HIV 1 & 2)
  • Human Immunodeficiency Virus Type 1 (HIV NAT)
  • Antibody to Hepatitis C (HCV)
  • Hepatitis C Virus (HCV NAT)
  • Hepatitis B Core IgG/IgM Antibody (HBcAb)
  • Hepatitis B Surface Antigen (HBsAg)
  • Rapid Plasma Reagin or Serologic Test for Syphilis (RPR or STS)

Additional tests including, but not limited to, Human T-Cell Lymphotropic Virus Type I & II (HTLV I & II) may have been performed at the time of donor screening and were found to be acceptable for transplantation.  A list of additional communicable disease test(s) performed may be provided upon request.

Microbial Testing:  Tissue is subjected to microbiological testing in the course of processing, and must be free of specific aerobic / anaerobic microorganisms and fungal contaminants whose presence would preclude tissue from processing or transplantation.

 

Indications for Use

For orthopedic use, Puros DBM RPM Putty with Chips and Paste, Cancellous are intended for use as an autograft extender (i.e. extremities, posterolateral spine and pelvis) and as a bone void filler (i.e. extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure.  The Puros DBM RPM products are indicated to be packed gently into bony defects of the skeletal system.  These defects may be surgically created or from the result of traumatic injury to the bone.

Puros DBM RPM Putty and Gel is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure.  Puros DBM RPM is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine and pelvis) and as a bone void filler of the extremities and pelvis.  These defects may be surgically created or from the result of traumatic injury to the bone.

 

Contraindications

Puros DBM RPM is contraindicated where the device is intended as structural support in load-bearing bone and in articulating surfaces.  Conditions representing relative contraindications include:

  • Severe vascular or neurological disease
  • Uncontrolled diabetes
  • Severe degenerative bone disease
  • Pregnancy
  • Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol
  • Hypercalcemia
  • Renal impairment
  • Patients with a history of or active Pott’s Disease
  • Active or latent infection in or around the surgical site

Polymyxin Sulfate B and Bacitracin are used in processing Puros DBM RPM and trace amounts may remain.  Since it is impossible to quantify the levels at which any individual may have an allergic response, this product is contraindicated in patients with known sensitivity.

 

Warnings and Precautions

Puros DBM RPM is sterile during the stated shelf life in an unopened and undamaged package.  The product must be used prior to the expiration date.

Do not use if the packaging has been damaged and/or the product has been contaminated.  In the event of contamination, discard the product.  Damaged packaging should be returned to Zimmer Spine.

Puros DBM RPM does not require rehydration prior to use.

Appropriate placement and/or fixation are critical factors in the avoidance of potentially adverse effects.  Do not over-fill the defect site.  As with all biological products, the tissue in Puros DBM RPM has the potential to transmit infectious agents despite processing treatments, extensive donor screening, tissue selection and laboratory tests.

As with any surgical procedure, the possibility of infection exists.

Although the production technique is designed to eliminate antigenic properties of the product, the possibility of such a reaction is present.

Adverse outcomes potentially attributable to the product must be reported promptly to Zimmer Spine.  If any dissatisfaction with the product performance or packaging occurs, notify Zimmer Spine immediately and promptly return product and/or packaging.

When filling a closed defect, care must be taken while extruding Puros DBM RPM from the syringe as possible pressurization of the device could result in fat embolization and/or embolization of the material into the bloodstream.

Overfilling the implantation site must be avoided to achieve a tension-free closure of the wound.

Legal Manufacturer:

Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminster, CO 80021 USA


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