Catalog Number 121887350 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Osteolysis (2377)
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Event Date 10/18/2021 |
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 on (b)(6) 2010, the patient underwent the tha surgery with the insert in question, other company¿s cup (pinnacle-a) and a s-rom a.After the surgery, the revision surgery was planned on (b)(6) 2021.It was found that osteolysis occurred around the proximal femur.Since the sleeve was well fixed, the sleeve was left as it was, and the stem and the head were replaced with new ones.The cup was other company¿s product, and it was replaced with a zimmer biomet¿s product.The revision surgery was completed successfully with no surgical delay.The surgeon commented that osteolysis occurred due to mom.Doi: (b)(6) 2010; dor: (b)(6) 2021; unknown side.
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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 : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
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Search Alerts/Recalls
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