(b)(6) medical product: unknown oss femoral component, cat#: unknown lot#: unknown, unknown oss bearings, cat#: unknown lot#: unknown, unknown oss tibial tray, cat#: unknown lot#: unknown, unknown oss assembly components, cat#: unknown lot#: unknown.Initial reporter: nathan f gilbert, md., alan w.Yasko, md., scott d.Oates, md., valerae o.Lewis, md., christopher p.Cannon, md., and patrick p.Lin, md.¿allograft ¿ prosthetic composite reconstruction of the proximal part of the tibia¿ analysis of early results the journal of bone and joint surgery¿ 2009,91:1646-56 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed,a supplemental medwatch 3500a will be submitted the reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05799, 0001825034-2017-05800, 0001825034-2017-05801, 0001825034-2017-05802.
|
This follow-up report is being submitted to relay additional information.Concomitant medical product: unknown oss femoral component, cat#: unknown lot#: unknown.Unknown oss bearings, cat#: unknown lot#: unknown.Unknown oss tibial tray, cat#: unknown lot#: unknown.Unknown oss assembly components, cat#: unknown lot#: unknown.Unknown oss stem, cat#: unknown lot#: unknown.Unknown patella, cat#: unknown lot#: unknown.The device will not be returned for analysis, as its location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05799, 0001825034-2017-05800, 0001825034-2017-05801, 0001825034-2017-05802, 0001825034-2017-06293, 0001825034-2017-06294.The information contained within this report does not alter previous conclusions.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.
|