Catalog Number 121722052 |
Device Problems
Disassembly (1168); Metal Shedding Debris (1804); Insufficient Information (3190)
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Patient Problems
Pain (1994); Discomfort (2330); No Information (3190)
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Event Date 10/12/2015 |
Event Type
Injury
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Manufacturer Narrative
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Additional narrative: 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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Patient was revised to address disassociation.
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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 11/04/2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.Upon revision, the patient was found to have moderate metal staining of the synovium and a poly that was rotated partially overlying the femoral head.The locking mechanism had failed with multiple locking tabs being worn away.There was significant striping of the ceramic femoral head.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 11/24/2015.
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Manufacturer Narrative
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Examination of the returned acetabular liner and femoral head and patient x-rays confirms the reported disassociation.Machining lines on the articulating liner surface counter to the visible bearing wear confirms the device was not evenly loaded.It is suspected the acetabular cup was positioned more vertically than recommended.The cup was not returned and is assumed yet implanted.A search of the complaints databases finds no related reports against the device product/lot code combinations.The investigation can draw no further conclusions with the information made 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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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 07/18/2016 medical records received.There is no new additional information that would affect the existing mdr decision.Update rec'd 07/14/2016 - legal claim received.The claim is consistent with the medical records, with additional allegations of pain and discomfort.Patient harms have been updated.There is no new additional information that would affect the existing mdr decision.
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Manufacturer Narrative
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Examination of the returned acetabular liner and femoral head and patient x-rays confirms the reported disassociation.Machining lines on the articulating liner surface counter to the visible bearing wear confirms the device was not evenly loaded.It is suspected the acetabular cup was positioned more vertically than recommended.The cup was not returned and is assumed yet implanted.A search of the complaints databases finds no related reports against the device product/lot code combinations.Medical records were reviewed.The investigation can draw no further conclusions with the information made available.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.
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Search Alerts/Recalls
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