(b)(4) medical records ad 27 aug 2021 were reviewed.On (b)(6) 2016, the patient had a right total knee arthroplasty to address end-stage osteoarthritis, mainly involving patellofemoral joint.Depuy components, including depuy patella and depuy cement x2 were utilized during this procedure.On (b)(6) 2021, the patient had a revision right total arthroplasty to address aseptic loosening.The femoral, tibial tray, insert, and patella were revised.The patient was negative for infection.During the procedure the surgeon observed moderate amount of synovitis as well as scar tissue.The insert showed no significant wear but was revised.The tibial tray was loose at the implant to cement interface.The femoral component was not loose to palpitation, but fairly quickly loosened after using a saw blade and osteotomes.The preoperative bone scan results showed the patella as loose.The patella was removed for concerns of loosening, but no loosening was noted during the procedure.Competitor components were implanted, including competitor patella and competitor cement x3.Doi: (b)(6) 2016 dor: (b)(6) 2021 (right knee).
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All photographs were reviewed and from the event information received, it was not possible to determine the relationship of the device to the reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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.
|