(b)(4).Brand name: liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells.Udi #: (b)(4).Concomitant medical products: item# 00620005420, shell porous with holes 54 mm o.D., lot# 61215875.Item# 00784301606, femoral stem beaded fullcoat 12/14 neck taper std.Body std.Offset size 16 16 mm distal dia.160 mm length, lot# 61601513.Item# 00625006525, bone scr 6.5x25 self-tap, lot# 61738462.Item# 00625006530, bone scr 6.5x30 self-tap, lot# 61724514.Item# 00877703603, biolox⮠option, head, l, 㸠36/+3.5, taper 12/14, lot# 2911123.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event; please see associated reports: 0002648920-2019-00122, 0002648920-2019-00121, 0001822565-2019-00768, 0002648920-2019-00120.
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Patient underwent revision due to chronic infection approximately 7 years post initial hip arthroplasty, and approximately 3 months following previous intervention due to infection.All implants were removed and spacers implanted.The reported liner in the event had been previously replaced 6 years post initial implantation.Attempts were made to obtain additional information; however, none was available.
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