Model Number 86-6403 |
Device Problems
Fracture (1260); Device-Device Incompatibility (2919); Unintended Movement (3026)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).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.
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Event Description
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It was reported that an x-ray image showed a metal component of the reaming device had come loose and remained in the femur.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device was not returned to depuy synthes for evaluation, however x-rays were provided for review.Review of the provided x-rays revealed unknown metal component remained in the femur.The potential cause is traced to user.The report allegation can be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Removed the reported date of implant in d6a.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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Event Description
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Additional information received.A.What was the affected side? left, or right? -right b.Was the revision surgery performed? -no e.Was there any surgical delay? if yes, please provide the duration.-no f.Was there any patient harm relevant to this event? if yes, please provide the details.-no.
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Search Alerts/Recalls
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