Catalog Number 150670004 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fibrosis (3167); Joint Laxity (4526)
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Event Date 04/15/2024 |
Event Type
Injury
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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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Event Description
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Patient needed a total knee arthroplasty revision because of an extended fibrosis in the joint capsule, which caused a flexion deficit and mid-flexion instability.
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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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Event Description
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Additional information received: a.Was there any surgical delay related to the event? no delay was identified.B.Was instability related to polyethylene wear? no instability was reported due to the polyethylene wear.C.Was there any reported malposition of components that led to the instability? no.D.Were any components undersized on the primary surgery that led to the instability? no.E.Was the femur or tibia excessively resected/joint line raised during the primary surgery that led to the instability? no.
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Search Alerts/Recalls
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