Catalog Number 136346000 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Fall (1848)
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Event Date 03/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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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The patient had a hemi hip replacement for a #nof and since this has fallen and dislocated her hip which required a closed reduction.This patient has again fallen , dislocating their hip joint.The surgeon was unable to reduce the hip joint and the implants were then removed.
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Manufacturer Narrative
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Conclusion and justification status: the complaint states procedure: hemi hip replacement.The patient had a hemi hip replacement for a #nof and since this has fallen and dislocated her hip which required a closed reduction.This patient has again fallen , dislocating their hip joint.The surgeon was unable to reduce the hip joint and the implants were then removed.Specimens were taken to test for infection.The stem was easily removed from the cement mantle after the head and sleeve had been removed.Primary procedure (b)(6) 2017.No other supporting data is available.A complaint database search and review of manufacturing records did not identify any anomalies.Without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (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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Search Alerts/Recalls
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