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.
