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Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Disconnection (1171); Noise, Audible (3273)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 10/01/2013 |
Event Type
Injury
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Manufacturer Narrative
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(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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"late nontraumatic dissociation of the femoral head and trunnion in a total hip arthroplasty" was reviewed for mdr reportability.The article covers a (b)(6) "women".She has a history of hip dysplasia."he" had a left hip implanted in 2002.In (b)(6) 2013, "he" stood from a seated position and heard a loud ¿clunk¿, followed by pain and difficulty with mobilization.Radiographs indicated a complete disassociation of the femoral head from the femoral stem.The femoral head remained within the acetabular cup.The patient was revised in (b)(6) 2013.During the revision, mild wear was noted on the trunnion.Black debris was noted around the inner surface of the head, likely to represent mild metallosis.The c-stem, 28mm cobalt chromium modular head, 28mm cocr metal liner, and cup were revised.
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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 code(s) was not provided.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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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Search Alerts/Recalls
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