Catalog Number UNK HIP ACETABULAR LINER METAL |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/19/2021 |
Event Type
Injury
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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 there is a head and liner exchanged.Liner appeared to be locked into cup.The surgeon was unable to remove the liner from the cup and had to remove cup as a result.Liner was not laying flush/in-line with shell rim, metal liner, metal head, and sector cup.It was also indicated that there was a surgical delay of 1 hour.Doi: unknown, dor: (b)(6) 2021, affected side: unknown hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The symptoms / reason for revision associated with this patient is not known.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: a device history record (mre) review, was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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