(b)(4).Concomitant medical products - humeral articulation kit, cat#: 00840009400, lot#: 63364034, humeral articulation kit, cat#: 00840009400, lot#: 63425394, humeral provisional size 4 100 mm, length cat#: 00840104410, lot#: 63418825, ulnar component plasma sprayed size 4 75 mm, length right, cat#: 00840002407, lot#: 63293923, humeral screw kit 2 humeral screws, cat#: 00840009000, lot#: 63250303.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.
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It is reported that during a primary total elbow arthroplasty, the bearing assembly tool did not work properly, causing the bearing assembly to not mate correctly with the cemented implants.An initial bearing assembly was attempted to be seated on the ulna, however during reduction with the humeral component, it was discovered that the assembly appeared too wide and would not allow reduction.This bearing kit was removed and replaced with a second assembly, however the same issue persisted and the bearings would not seat symmetrically causing difficulty with reduction.The elbow was eventually reduced properly following a 30-40 minute delay to the procedure, however one set screw was still difficult to tighten/seat and was left implanted 1-2 mm proud.No additional patient consequences were reported.
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Complaint sample was evaluated and the reported event was confirmed.Functional check performed with returned part and sample devices.The assembly tool performed as intended and was able to assemble the system together.The screw sat as intended.As returned, the articulation kit exhibited damage which is consistent with the repeated attempts made by the surgeon.Functional test was not performed on this articulation kit due to the damages.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined.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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