Johnson & Johnson DePuy S-ROM Información Importante página 6

The inner diameter of the acetabular components and the femoral head size must cor-
respond.
Always check the dimensions of trial components to ensure that they match with actual
inventory available.
Use a 2.7mm or 7/64" drill with 3.5mm diameter peripheral screws.
Use a 3.5mm or 9/64" drill with 5.0mm diameter peripheral screws.
Use a 3.2mm or 1/8" drill with 6.5mm diameter dome screw.
Use locking pins with 0°, 10°, 15° nonconstrained liners.
Contraindications
Use is contraindicated in cases with active or recent joint sepsis, insufficient bone stock,
marked atrophy or deformity of the upper femur, skeletal immaturity, or where loss of muscu-
lature or neuromuscular disease would render the procedure unjustifiable.
Use is contraindicated in cases with metabolic disorders of calcified tissues or other indica-
tions of poor osteogenic potential such as chronic alcohol abuse, recent high doses of
corticosteroids, or recent therapeutic levels of radiation.
Adverse Effects
Peripheral neuropathy, deep wound infection, and heterotopic bone formation have been
reported following hip replacements. Subclinical nerve damage has also been reported more
frequently, often associated with surgical trauma. Dislocation and subluxation resulting from
improper positioning and/or muscle and fibrous tissue laxity also may occur, as may loosen-
ing and subsequent failure of total hip prostheses.
Histological reactions have been reported as an apparent response to exposure to a foreign
material. The actual clinical significance of these reactions is unknown.
Implanted metal alloys release metallic ions into the body. In situations where bone cement
is not used, higher ion release due to increased surface area of a porous-coated prosthesis
is possible.
There have been reports of failure of bone to grow into porous surfaces and fix components.
Shedding or fragmentation of the porous surface has been reported, with potential for
release of metallic debris into the joint space. Radiolucencies of bone adjacent to porous
surfaces have been noted, although the clinical significance of this observation is uncertain
in many cases.
Serious adverse effects may necessitate surgical intervention.
Sterility and Handling
Do not resterilize products that are HA-coated or porous-coated; products that are ceramic;
or, products that contain plastic components. Resterilization can cause changes to the
mechanical and physical properties of these components.
Metal products that do not contain plastic or ceramic components and are not HA-coated or
porous-coated may be resterilized.
For Metal Components Only: If the sterile packaging appears damaged, the device must
be cleaned and sterilized prior to implantation, according to the following instructions. If the
sterile implant is determined to be aseptically compromised but still acceptable for intended
use based on physician determination, the implant must be rinsed and sterilized prior to
implantation according to the following instructions.
Cleaning
Use sterile room temperature water or physiological saline to soak the implant. Soak the
implant for a minimum of 5 minutes. Immediately dry the product. Inspect the implant prior
to sterilization.
6