Catalog Number UNK-HIP |
Device Problems
Disassembly (1168); Device Dislodged or Dislocated (2923)
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Patient Problems
Bone Fracture(s) (1870); Unspecified Infection (1930)
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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.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
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Event Description
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Legal claim/letter received.Information received is from the patient's surgeon that indicates the patient was revised from an asr implant ((b)(4)) and later developed dislocation, displaced cup, acetabular fracture, disassocation, and infection with spacers placed.The surgeon is indicating these failures are a result of the initiate asr hip and depuy/broadspire are to reinburse him for the care provided to the patient as they didnt have insurance.
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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 and/or a review of device history records were not possible as the required product/lot code combinations were 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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