Catalog Number 126156526 |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Information (3190)
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Event Date 10/17/2016 |
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Depuy synthes has been informed that the lot number is not available.
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Event Description
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Patient was revised to address poly wear, which caused a leg length discrepancy and dislocation.
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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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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