(b)(4).Concomitant medical product(s): unknown ulna; unknown articulation kit.Report source: foreign: event occurred in (b)(6).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00892.Device evaluated by mfr: product not returned.
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D11: item# 00840001407; lot# 63710294; ulnar component plasma sprayed size 4 75 mm length.Item# 00840009000; lot# 64093871; humeral screw kit 2 humeral screws.Item# 00840009500; lot# 64102160; articulation kit. item# 66017787; lot# 89444785; palacos lv + g (1x40).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and x-rays which indicates premature loosening of humeral and ulnar left elbow prosthesis.Patient was presented with increasing load-dependent pain, complete loosening between the bone-cement interface as well as humeral and ulnar components.Visual examination of the returned product identified that the humeral and ulnar components contain large amounts of bone cement.The poly on the articulation kit components exhibit wear.Screw kit not returned.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.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: 0001822565-2020-00892, 0001822565-2020-02970.
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