Catalog Number UNK HIP ACETABULAR CUP |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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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Patient was revised due to metal on metal liner extraction.Had the suction cup and mom removal tamp that screws to pinnacle cup handle there and ready to go.Followed all instructions on how to remove the liner, but it wouldn't budge.He banged on the liner trying to remove for an hour, complaining how our instruments don't work the whole time.Then he decided to put the same head back on and close the patient up against recommendation.There was surgical delay of an hour.Doi: unknown.Dor: (b)(6) 2023.Affected side: unknown.
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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 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 manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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