Catalog Number 121732054 |
Device Problems
Disassembly (1168); Noise, Audible (3273)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); No Information (3190); No Code Available (3191)
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Event Date 11/10/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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Clinical report states patient was revised to address disassociation and femoral stem subsidence.
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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.
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Event Description
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Update rec'd 01/08/2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, the patient was bending over and felt their hip sublux and then pop back into place.Following that episode the hip was painful and squeaking.Upon revision black stained synovium was encountered; early metallosis of the synovial with metallic striping of the femoral ball.The liner was dislocated inferiorly.The ceramic femoral ball was articulating with the upper inner quadrant of the metal cup.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 01/27/2016.
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Manufacturer Narrative
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Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other related reports against the product and lot code combinations since their release to distribution.Medical records were reviewed.The investigation can draw no conclusion with the information provided.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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