Patient was revised due to surgeon thought that the patella was too thick causing some pain and low limited rom.The patella implant, tibial insert and femoral component were explanted.More patella bone was resected, the femur was downsized to a size 3 with a crs femoral component.The tibial base plates was left in situ.Patient had done her knee by a surgeon on (b)(6) 2020 at (b)(6).Doi: (b)(6) 2020 (femoral & patella), (b)(6) 2021 (tibial insert), dor: (b)(6) 2021, right knee.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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