S-ROM Prescribing Information

S-ROM Total Hip Prosthesis System

Important:

This Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information.

Indications:

Total Hip Arthroplasty (THA) is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The components of the S-ROM Total Hip System are indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

Contraindications:

Use is contraindicated in cases with active or recent joint sepsis, insufficient bone stock, marked atrophy or deformity in the upper femur, skeletal immaturity, or where loss of musculature or neuromuscular disease would render the procedure unjustifiable.

Warnings and Precautions

The following conditions tend to adversely affect hip replacement implants: excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, disabilities of other joints.

S-ROM femoral heads with +12 neck length extension are contraindicated for use with the POLY-DIAL™ constrained liner. Use of the Alumina ceramic head without the preassembled taper adaptor is contraindicated. The zirconia ceramic heads, 28mm diameter +0 neck length and +6 neck length, are indicated for use only with the S-ROM standard neck femoral stem and the S-ROM calcar replacement system. In the United States, the ceramic femoral heads are indicated for use only with acetabular shells composed of UHMWPE, metal-backed UHMWPE, or ceramic. Do not use ceramic heads with constrained acetabular liners. The femoral head size and the inner diameter of the acetabular components must correspond. ZT, ZT HA, and ZTT oversized proximal sleeves must be used with S-ROM stems having a nominal proximal diameter 2 mm smaller than the nominal diameter of the sleeve. For all other S-ROM proximal sleeves, the nominal proximal stem diameter must correspond with the nominal diameter of the sleeve. The trochanter screws and washers must be used together with the S-ROM 36+21 calcar replacement neck femoral stem.

Adverse Events

Peripheral neuropathy, deep wound infection, and heterotopic bone formation have been reported following hip replacements. Subclinical nerve damage has also been reported. Dislocation, subluxation, muscle and fibrous tissue laxity, and loosening may also occur.

The ceramic femoral heads are composed of new ceramic materials with limited clinical histories. Because of the limited clinical and preclinical experience, the long-term biological effects of these particulates are unknown. Histological reactions have been reported as an apparent response to exposure to a foreign material.