English; Contraindications - Depuy Synthes GRIPTION TF Wichtige Informationen

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CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION – DePuy GRIPTION™ TF Acetabular Augment System
The DePuy GRIPTION TF Acetabular Augments, Buttresses and Shims are indicated for use with the PINNACLE® Acetabular
Cup System, the PINNACLE® Bantam Acetabular Cup System and the PINNACLE® Revision Acetabular Cup System for total hip
replacement, and are intended to provide the orthopaedic surgeon with a prosthetic alternative to structural allograft in cases
of segmental acetabular deficiencies.
Materials:
Acetabular Augments
Buttresses
Shims
6.5mm PINNACLE Bone Screws
5.0mm Non-Locking Peripheral Screws
5.5mm Locking Screws
INDICATIONS
The DePuy GRIPTION TF Acetabular Augments, Buttresses and Shims are indicated for use
Cup System, the PINNACLE Bantam Acetabular Cup System and the PINNACLE Revision Acetabular Cup System for
replacement in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip
dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface
replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The porous GRIPTION TF titanium acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical
screw fixation. The assembled augment/acetabular cup construct is intended for cemented or cementless use.
The porous GRIPTION TF titanium shim is affixed to the mating buttress using bone cement. This porous GRIPTION TF titanium
buttress is affixed to the mating acetabular cup using bone cement. The GRIPTION TF titanium buttress/shim is affixed to
the bone using bone cement or mechanical screw fixation. The assembled buttress/acetabular cup construct is intended for
cemented or cementless use.

CONTRAINDICATIONS

Absolute contraindications include: infection, sepsis, and osteomyelitis.
Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who is incapable of following
directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of
infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on
roentgenogram, and/or 7) vascular insufficiency, muscular atrophy, or neuromuscular disease.
NOTE: Diabetes, at present, has not been established as a contraindication. However, because of the increased risk for
complications such as infection, slow wound healing, etc., the physician should carefully consider the advisability of hip
replacement in the severely diabetic patient.
WARNINGS AND PRECAUTIONS
CAUTION:
• Acetabular screws are to be fully seated to assure stable fixation and to avoid interference with the acetabular liner
component.
• Perforation entirely through the pelvic bone with dome fixation screws or rim screws is to be completely avoided.
Perforation through the pelvic bone with screws through the Buttress/Shim is also to be avoided. Caution is to be used
when determining and selecting the length of screws to be used, as perforation through the pelvic bone with screws that
are too long can cause damage to body structures (blood vessels, etc.) located on the interior side of the pelvis.
• Tight fixation of all non-cemented components at the time of surgery is critical to the success of the procedure. Each
component must properly press fit into the host bone which necessitates precise operative technique and the use of
specified instruments. Bone stock of adequate quality must be present and appraised at the time of surgery.
• Care is to be taken to assure complete support of all parts of the device embedded in bone cement to prevent stress
concentrations, which may lead to failure of the procedure. Complete pre-closure cleaning and removal of bone cement
debris, metallic debris and other surgical debris at the implant is critical to minimize wear of the implant articular surfaces.
• Porous titanium augments must be attached to the acetabular shells using acrylic bone cement or screw fixation.
• Porous titanium buttresses must be attached to the acetabular shells using acrylic bone cement.
• Porous titanium shims must be attached to the buttress implants using acrylic bone cement.
INSTRUCTIONS FOR USE
Commercially Pure (CP) Titanium
Commercially Pure (CP) Titanium
Commercially Pure (CP) Titanium
Ti-6Al-4V ELI
Ti-6Al-4V ELI
Ti-6Al-4V ELI
4
with the PINNACLE Acetabular
total hip