(b)(4).Ogura, k., yakoub, m.A., boland, p.J., healey, j.H.(21 apr 2021).Finn/orthopaedic salvage system distal femoral rotating-hinge megaprostheses in oncologic patients.The journal of bone and joint surgery, inc.103 (8), 705-714.Http://doi.Org/10.2106/jbjs.20.00696.Concomitant medical products - 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 axel 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 initial reporter name and address: 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: 0001825034-2022-01094, 0001825034-2022-01095, 0001825034-2022-01096, 0001825034-2022-01097, 0001825034-2022-01099, 0001825034-2022-01100, 0001825034-2022-01102, 0001825034-2022-01103, 0001825034-2022-01105.Insufficient information,.
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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.H6 - component code - proposed code is mechanical (g04) - stem 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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