(b)(4).Rossi, s.M.P., sangaletti, r., nesta, f., matascioli, l., terragnoli, f., benazzo, f.(30 jul 2022).A well performing medial fixed bearing uka with promising survivorship at 15 years.Archives of orthopaedic and trauma surgery 143(5), 2693-2699.Https://doi.Org/10.1007/s00402-022-04562-7.B3 - date of article publication; the date of the incident is unknown.D6a - all patients were implanted between (b)(6) 2005 and (b)(6) 2007.D10 - concomitant devices - unknown zimmer unicompartmental knee tibial tray catalog #: ni lot #: ni, unknown zimmer unicompartmental knee articular surface catalog #: ni lot #: ni.E1 - correspondence author.G2 - report source - foreign: italy.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as additional information concerning each case cannot be released.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: 0001822565-2023-01511.
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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) - femur.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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