It was reported that during an initial knee arthroplasty the bearing spun out and fell off to the posterior joint capsule side.The surgeon then decided to use a different system, and the femur and tibia components were removed.During removal, the patient¿s femur bone cracked.Surgery was delayed for about 40 minutes.Attempts have been made and no further information has been provided.
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(b)(4) concomitant medical devices: oxf ph3 cementless fem sz xsm; item# 154912; lot# 7055221, oxf uni tib tray sz b rm pma; item# 154721; lot# 7083494.Reportv source foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00249, 3002806535-2022-00251.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.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.Dimensional analysis determined that the product, where measured, was oversize to print specifications for dimensions a, b and c.This is as expected because the bearing has likely been autoclaved sterilised at the hospital before return and also has been additionally soaked sterilised for 5.5 hours upon return.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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