The patient was revised due to knee pain and loosening of the tibial tray at the cement to implant interface.Depuy smartset medium viscosity bone cement would have been used in the primary procedure, since the hospital only stocks smartset cements.The product codes and the lot numbers for the cement used are not available, since the hospital orders their cement directly from depuy synthes.All of the patient's primary components, with the exception of the attune medialized patella implant, were removed and replaced by attune revision components.Surgeon believes there was a flaw in the design of the underside of the original attune tibial trays, since he has had to revise more than a half dozen attune cemented fb tibila trays due to loosening.The debonding interface for the majority, if not all of them of those surgeries, was the cement/implant interface.Doi: (b)(6) 2015, dor: (b)(6) 2022, affected side: right knee.
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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: added: d9 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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