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Literature article received entitled "catastrophic failure due to massive osteolysis of both acetabular and femoral components in a metal-on-metal hip arthroplasty: a demonstrative case report".Literature article entitled, ¿catastrophic failure due to massive osteolysis of both acetabular and femoral components in a metal-on-metal hip arthroplasty: a demonstrative case report¿ by gabriel gutman and oded hershkovich, et al, published by the european journal of orthopaedic surgery and traumatology (2013), vol.23, supplement 2, pp.S225-s228 was reviewed for mdr reportability.This case report represents an unusual situation in a (b)(6) year-old woman in which extensive lysis derived in massive femoral osteolysis and hip arthroplasty catastrophic failure.A (b)(6) year-old woman with a medical history of hypertension, carotid stenosis and glaucoma, who had a bilateral total hip arthroplasty for advanced osteoarthritis.On the right side, the patient was implanted with a pinnacle cup, a size 9 corail stem, a 36-mm cocr head, and ultamet liner.On the right side, the patient had the same implants with the exception of the stem, which was a corail size 10.After index tha, component position was acceptable in both limbs and the patient initially complained of vague right hip pain and later a more pronounced left hip pain.Laboratory tests and x-rays were unremarkable.The postoperative period was uneventful with return to full normal activity within 3 months, but the left hip pain did not resolve.After the first year the patient was at follow up once a year.During four consecutive years xr were normal with no sign of osteolysis.At 5 years follow-up, there was a severe deep aching pain in the groin and buttock that radiated down the anterior thigh to the knee in the left hip, the pain was unacceptable, and the patient was limited in daily activity.Complete blood count, c-reactive protein, and erythrocyte sedimentation rate were all within normal limits.Patch test of nickel sensitivity eventually was reported to be positive.She had no history of cutaneous metal sensitivity.She had noticed no rashes or irritation around the hip, or any other cutaneous reaction.Blood, urine, and fluid extracted from a hip aspiration were analyzed for chrome and cobalt levels; she had slightly elevated urine and blood level of cobalt, elevated urine level of chrome, and a high level of both cobalt and chrome of the hip fluid.Her white blood count from the fluid aspiration was 1.32 k/l/l with 57 % of pmn.On examination, the patient had a pronounced antalgic gait with tenderness at the proximal left femur.An otherwise acceptable range of motion was present in both hips.Analysis of the radiographs showed massive osteolysis around the left and right femoral stem mostly and mild bone lysis around the left acetabular cup.Intraoperatively, there was a very significant amount clear fluid and pericapsular hypertrophic soft tissue.Incision of the capsule revealed a copious amount of debris and hypertrophic, necrotic tissue.The femoral stem was loose and easily extracted, and significant osteolytic and erosive changes were noted in the proximal femur.The acetabular shell was stable after debridement of the hypertrophic tissue.Intraoperative decision was taken to keep the shell and to remove the previous screw and augment the shell with a new single screw.Metal concentration for chromium and cobalt resulted to be increased in the hip fluid.Histopathological dyeing showed chronic inflammation and foreign body giant cells surrounding bone tissue spicules (negative on polarized light examination) and necrotic bone and granulation tissue.Postoperative follow-up at 3 weeks and 3-month period was uneventful with resolution of here left hip pain and return to full normal activity.The right hip remained painful, but her decision at that point was to wait with the second revision of the right hip for later on.This patient had bilateral tha.Only the left stem, liner, and head were revised.The patient had confirmed elevated serum ions and revision of the right hip was recommended, but she refused.Radiographs showed massive left and right femoral osteolysis, and the patient reported significant pain of the right and left side.Joint aspiration found inflammation, microscopic foreign body particles, and elevated ions within the synovial fluid of both hips.The osteolysis of the right hip was not confirmed intraoperatively, however, there are a series of radiographs that identify the progression of the osteolysis in both hips.
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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