Model Number 1217-22-052 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Not Applicable (3189); No Code Available (3191)
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Event Date 07/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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(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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Liner breakage& cup deformed.It was reported that during the surgery of total hip replacement operation, after insert the liner in place, knocked it, the liner was broken off, could not only removed the liner, removed the both liner and cup.Changed one size bigger implants to complete the surgery.The surgeon suspect may the cup was deformed or liner with some issue.The surgery delayed about half hour.The bone appearance was damaged, lost about 30ml blood.The patient is stable and in hospital now.
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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 : examination of the returned acetabular cup finds no evidence indicative of a product problem.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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.
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Search Alerts/Recalls
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