Cmp-(b)(4).The product has been retained by the patient and will not be returned to zimmer biomet for investigation; however, an investigation has been initiated.Upon completion of the investigation, a follow-up mdr will be submitted.(b)(4).Concomitant product - g7 acetabular shell p/n 010000662 l/n 3626596; g7 screw p/n 010000998 l/n 3624605; g7 screw p/n 010000999 l/n 3604098; femoral stem p/n 00771100600 l/n 61963053; biolox femoral head p/n 00877403201 l/n 2811973.Multiple mdr reports were filed for this event.Please see associated reports: 0001825034-2017-03505.0001825034-2017-03545.
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It was reported that the patient underwent a revision procedure three months post-implantation due to range of motion complications, squeaking during ambulation and disassociation of the liner from the acetabular shell.The liner reportedly migrated around the femoral head, resulting in the femoral head articulating with the acetabular metal shell.The surgeon indicated that one of the acetabular screws may not have been fully inserted, which would interfere with full seating of the liner.During the procedure, the acetabular screws, liner, apical hole plug and ceramic head were removed and replaced.No additional patient consequences were reported.
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