(b)(6).Multiple mdr reports were filed for this event.Please see reports: 0001825034 - 2017 - 06322, 0001825034 - 2017 - 06566, 0001825034 - 2017 - 06567.Medical devices- p/n 010000850 g7 neutral e1 liner 32mm l/n 6029297; p/n 010000928 g7 hi-wall e1 liner 32mm f, l/n 3841590; p/n 110010246 g7 osseoti 4 hole shell 56mm f 6mm f, l/n r3667101b; p/n 110024464 g7 dual mobility liner 44mm f, l/n 636070.The device has not been returned for evaluation at the time of this reporting.Follow up attempts are being done for the device(s) and/or additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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(b)(4).This follow-up report is being submitted to relay additional information.Meaningful dimensional evaluation of the returned device was not possible as the device was impacted and therefore its specifications deformed.Upon inspection, the locking feature and outer radius show no signs of damage.The scallops show damage from impaction and there is an impaction ring on the flat side of the liner.Review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.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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