Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A review of provided x-ray images is unable to identify and allegations associated with the acetabular liner.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.(b)(4).
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Clinical adverse event received for poorly positioned acetabular component : abnormal radiographic evaluation event is serious and is considered moderate.Event is definitely related to device and is definitely not related to procedure.Medical records received on 31 jul 2020 and 3 aug 2020 were reviewed to identify patient harms/product issues.On (b)(6) 2003, the patient underwent a a right hip revision involving the removal of an unknown hip due to pain, poly wear, and osteolysis.A depuy s-rom 60 mm deep profile +6 ztt cup, with two dome screws and one rim screw, along with one rim pin, and a 32 mm inner diameter 10 degree posterior-lipped +3 lateralized depuy liner were implanted.On the femoral side, howmedica product was implanted.On (b)(6) 2014, the patient underwent a right hip revision due to a worn, fractured, and dislocated liner.The patient was also experiencing grinding and instability.The surgeon noted slight wear on the depuy cup and minimal lysis.The cup was well ingrown and not revised.An s-rom lipped liner was implanted with one locking screw and one locking pin.The surgeon indicated the cup had minimal anteversion, but felt the cup gave the patient good stability with the newly implanted liner.Event is captured on (b)(4).On (b)(6) 2020, the patient presented for a right hip evaluation due to audible popping/clunking, audible and palpable subluxation, possible early osteolysis, poorly positioned cup, and instability.The surgeon indicated the patient was a candidate for revision.There is no evidence of a revision involving this event.Event is captured on (b)(4).Date of implantation: (b)(6) 2003.Date of revision: (b)(6) 2014 (acetabular liner and competitor femoral head) (right hip).
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