Model Number 1012-14-060 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Device-Device Incompatibility (2919)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (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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It was reported that the stem did not implant to the level of the same size broach.Implant did not match broach.There was a surgical delay of 3 minutes.Doe: (b)(6) 2020, affected side: right hip.
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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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: related dimensional inspection performed on the returned device found no discrepancy from drawing requirements.The device manufacturing records have been reviewed.No deviations or anomalies identified.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: lot j67k04.The device manufacturing records have been reviewed.No deviations or anomalies identified.Device history review: the device manufacturing records have been reviewed.No deviations or anomalies identified.
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Search Alerts/Recalls
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