(b)(4).Ogura, k., fujiwara, t., morris, c.D., boland, p.J., healey, j.H.(1 aug 2021).Long-term competing risks for overall and cause-specific failure of rotating-hinge distal femoral arthroplasty for tumour reconstruction.The bone & joint journal.103-b (8), 1405-1413 https://doi.Org/10.1302/0301-620x.103b8.Bjj-2020-2323.R1.Concomitant devices - unknown orthopedic salvage system tibial stem catalog #: ni lot #: ni, unknown orthopedic salvage system femoral stem catalog #: ni lot #: ni, unknown orthopedic salvage system femoral component catalog #: ni lot #: ni, unknown orthopedic salvage system tibial tray catalog #: ni lot #: ni, unknown orthopedic salvage system tibial bearing catalog #: ni lot #: ni, unknown orthopedic salvage system yoke catalog #: ni lot #: ni, unknown orthopedic salvage system tibial bushing catalog #: ni lot #: ni, unknown orthopedic salvage system femoral bushings catalog #: ni lot #: ni, unknown orthopedic salvage system locking pin catalog #: ni lot #: ni.Occupation- correspondence author.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the device is unknown.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 patient; please see all reports associated with this event: 0001825034-2022-01024, 0001825034-2022-01025, 0001825034-2022-01026, 0001825034-2022-01027, 0001825034-2022-01028, 0001825034-2022-01029, 0001825034-2022-01031, 0001825034-2022-01032, 0001825034-2022-01033.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h6, h10.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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