(b)(4).Concomitant medical devices ¿ persona tibial articular surface provisional right size ef catalog #: 42527000505 lot #: 62868843, persona tibial articular surface provisional left size ef catalog #: 42517000505 lot #: 62752807.The product has been received by zimmer biomet and the investigation is in process.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: 0001822565-2018-04223, 0001822565-2018-04224.
|
This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned tibial articular surface provisional (tasp) exhibited signs of repeated use (nicked or gouged) and the anterior section of the post feature had fractured off with not all pieces returned.The device history records were reviewed and no discrepancies were identified.A root cause could not be determined with information available as frequency of use is unknown, a condition of use is unknown and surgical technique was followed.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.
|