(b)(4).Multiple mdr reports were filed for this event, please see associated report: (b)(4).Associated product bmt 360 tib aug 63x5mm item# 185221 lot# 904740, bmt 360 tib aug 67x5mm item# 185222 lot# 947570.(b)(6).The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
It was reported that, during a knee procedure, a screw didn't mate with the tibial augment.Subsequently, a screw for an alternative augment was used to complete the procedure.There is no additional information at this time.
|
This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.Corrected: d1, d4, and g4 visual inspection of the returned screw components found both to exhibit some cosmetic damage one of the screw threads were found to be damaged and the second screw threads were conforming.However, it is not confirmed which screw was the one used with reported part.Medical records were not provided.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause cannot be confirmed.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.
|