Catalog Number UNK-HIP |
Device Problems
Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408)
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Patient Problem
Pain (1994)
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Event Date 11/12/2014 |
Event Type
Injury
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Event Description
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Patient was revised to address subsidence of stem.Pain, leg length discrepancy and instability were also reported.It was also noted the surgeon felt the stem looked undersized.
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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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy synthes has been informed that the catalog number and lot number is not available.
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Manufacturer Narrative
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Examination of the reported device was not possible as it was not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combination was not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.
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Search Alerts/Recalls
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