The complaint number corresponding to this medwatch is (b)(4).The device has been returned, but the device investigation has not yet been completed.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: 0002648920-2017-00062, 0002648920-2017-00228, 0002648920-2017-00229, 0002648920-2017-00230 & 0002648920-2017-00231.
|
During a procedure, there was difficulty assembling the acetabular cup with the liner on the back table.After attempting to assemble two different liners, it was discovered that the locking ring was bent inside of the acetabular cup and tabs in the cup were not aligned properly.Another cup and liner were used to complete the procedure without a significant delay.
|
(b)(4).Concomitant medical products: 00500104600, bipolar shell, 62430399, 00500104428, bipolar liner, 63431201, 00801802802, versys femoral head, 63482107, 00801802802, versys femoral head, 63482109.Complaint sample was evaluated and the reported event was confirmed.A bipolar shell, and two bipolar liners were returned for evaluation.As returned, one of two tabs of the lock ring is seized in the lock ring groove of the bipolar shell.Both liners exhibit damage that indicates the lock ring tab was not in its¿ intended position prior to the attempt to install the liners.Dimensional readings of the lock ring and lock ring groove are conforming to print specifications.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.
|