(b)(4).Concomitant medical products: 00620004822-shell porous with cluster holes 48 mm o.D.- 61237814, 00625006525-bone scr 6.5x25 self-tap-61265367, 00631004832-liner 10 degree elevated rim 32 mm i.D.For use with 48 mm o.D.Shell- 61276771, 00877503202- biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14- 2764111.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00032, 0001822565 - 2021 - 00061.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported the patient underwent a left hip revision approximately 10 years post implantation due to aseptic loosening of the acetabular shell.During the procedure, upon entering the deep tissue, patient did have mild damage of the abductor muscle; therefore, active articulation bearing placed and it band tenodesis performed.Acetabular component was grossly loose and easily removed; 2 screws were broken through the cup but also easily removed.Appears screws pulled through the shell holes but not actually fractured.The biolox head, initial liner, and initial shell replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.
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