Catalog Number 122132252 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/01/2024 |
Event Type
Injury
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Event Description
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The patient underwent revision due to liner damage/wear.Affected side: right.
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Manufacturer Narrative
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Product complaint # (b)(4).D6, h4: the information provided regarding the manufacturing date and implantation date are identified to be conflicting.Continued follow-up is being conducted and any additional information received will be reported.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).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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Event Description
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Additional information was received: 1.Was there any patient harm relevant to this event? if yes, please kindly provide details.Yes ¿ two hip revisions.2.Was there a surgical delay? if yes, what is the duration of the delay? no.3.What was the reason for the primary revision and secondary surgery? liner damage.4.Kindly confirm why the cup was revised? was there any allegation against the cup? to eliminate the acetabulum as the cause of liner damage doi: (b)(6) 2018, dor: (b)(6) 2023, affected site: right.
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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.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 122132252/lot m40c81 combination.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.If additional information is made available, the investigation will be updated as applicable.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 122132252/lot m40c81 combination.
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Search Alerts/Recalls
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