Catalog Number 3095020 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Adhesion(s) (1695); Cyst(s) (1800); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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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The patient was revised to address pain and loosening of an unknown component.Depuy was used.Doi: (b)(6) 2019.Dor: (b)(6) 2020; left knee.
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Event Description
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Medical records received were reviewed: on (b)(6) 2019, the patient underwent a primary left knee arthroplasty with implantation of depuy unicondylar sled prothesis to treat osteoarthritis.Depuy cement was utilized during the procedure.The patella was not resurfaced.There were no indicated intra-operative complications.On (b)(6) 2020, the patient underwent a left knee revision to address pain, adhesion, cysts, crepitus, and tibial tray loosening at the cement to implant interface.All components were removed, and the patella was resurfaced.Depuy products were implanted with depuy cement.Revision is captured on (b)(4).Task created to update pc.On (b)(6) 2021, a left knee x-ray revealed osteolysis beneath the tibial plateau.On (b)(6) 2021, a left knee ct revealed possible tibial tray loosening.On (b)(6) 2021, the patient underwent a left knee aspiration to rule out infection due to increasing pain.The physician aspirated 15 ml of blood-tinged clear effusion and sent for microbiology and cell count.Results of aspiration not given within the available medical records.The physician also indicated a request for allergy testing for the bone cement.No results available regarding an allergy to bone cement.Task created to update (b)(4) with information involving events from 6 jan 2021 to 27 jan 2021.There is no evidence of a second revision involving the left knee.
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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.H10 additional narrative: h6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the joint crepitation (musculoskeletal system)(e16) 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.This device was manufactured on 26-nov-2018.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 : 1) quantity manufactured: (b)(4).2) date of manufacture: 26-nov-2018.3) any anomalies or deviations identified in dhr: none.4) expiry date: 31-oct-2020.5) ifu reference: ifu-0630004.Device history review : 0 non-conformances on this lot number.Final micro and sterility tests passed.All qc release specifications met.
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Search Alerts/Recalls
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