Model Number 2975-24-105 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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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Reclaim hip revision.(b)(6) 2020.During reaming of the proximal body the loose parts of the couloured rings were noticed.They used extra pulse lavage to decrease the risk of parts in the patient.
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Manufacturer Narrative
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Product complaint # (b)(4).Corrected: b9: date devices returned.H3: device evaluation information.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Corrected: b9: date devices returned.H3: device evaluation information.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes 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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