Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Corroded (1131)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Osteolysis (2377); No Code Available (3191)
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Event Date 11/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(b)(4).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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Event Description
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Unf and medical records received.After review of medical records the patient complains of progressive right hip pain.The patient was then revised for metal-on-metal right total hip arthroplasty with metalosis.Operative notes reported that the it band was found to be adhered anteriorly with what appeared to be a pseudotumor formation in the lateral aspect of the femur, this was directly communicating with the hip joint.There was significant abductor atrophy as well as chronic tearing noted.Significant capsular hypertrophy was noted.There was significant gray-colored debris noted within the hip joint and gray-colored fluid was also found.The trunnion was found to be in good shape, although some metal debris was noted between the trunnion and the ball.Osteolysis was noted on both acetabulum and femur, however both components are well fixed.Doi: (b)(6) 2006; dor: (b)(6) 2018; right hip.The patient has bilateral hip implants, please see (b)(4) for the left hip.
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Search Alerts/Recalls
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