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Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Inflammation (1932); Pain (1994); Pocket Erosion (2013); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)
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Event Date 08/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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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Pinnacle claim submission form and medical record received.After review of medical records, the patient was revised to address periprosthetic osteolysis.Revision notes reported that there is a clear yellow fluid noted within the hip joint, erosion is noted at the trunnion, visibly loose proximal aspect of the femoral stem, black brown inflammatory tissue, synovitis with black stained material, and osteolysis due to metal wear.A trochanteric osteotomy was done to remove the stem since there was still bone ingrowth distally; this was then cabled.Clinical visits reported elevated metal ions and pain.Doi: (b)(6) 2007 - dor: (b)(6) 2017, (left hip).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by 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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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