Catalog Number 121731046 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that the liner disassociated during reduction.Surgical delay 15 minutes.Doe: nov 13, 2023.Affected side: unknown 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 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 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 an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.
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Event Description
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Additional information was received and stated: a.Was there any surgical delay? if yes, what is the duration of the delay? yes there was a delay.Dr matthys had to return to acetabular side and reimplant a new liner.Appx 15 mins b.Was/were there any patient consequence/s related to the event? just the delay.C.Please provide the product code and lot no.Of unknown hip acetabular cup? liner information is in the mdr.The acetabular shell was 1217-31-046.M32n13.D.Will the unknown hip acetabular cup available for return? yes e.Why the liner became disassociated from the cup? i¿m not sure why.Dr matthys feels it was edge loading of liner during the reduction of the joint.
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Search Alerts/Recalls
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