Catalog Number UNK ANKLE TIBIAL INSERT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 05/29/2020 |
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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Patient underwent a revision of her right mobility ankle bearing due to pain and stiffness.Upon opening, the joint was stiff and had large amounts of fibrous tissue which seemed to be limiting movement.Mr (b)(6) removed the fibrous tissue and primary bearing, re-trialed the ankle with a trial bearing and then implanted a new size 2 - 3mm mobility ankle bearing (ref: (b)(4), lot:9440660).
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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 reported incident(s) against the provided product/lot combination(s) 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.Corrective action was not indicated.Corrected h6 patient code: no code available (3191) from the initial medwatch to capture patient harm musculoskeletal stiffness.
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Search Alerts/Recalls
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