(b)(4).Report source, foreign - event occurred in (b)(6).Concomitant medical products: avantage curved handle; item #: 110031337; lot #: 315950.Recall was performed on the affected item.This item was not delivered to the usa.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.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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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: e1, g1-2, g4, h2, h3, h6, h7, h10 h3 - the device evaluation was not performed as the product was not returned and the batch number was not communicated.H7 - recall was performed on the affected item.The manufacturing review was not performed as the batch number was not communicated.However, other similar products were returned to zimmer biomet.An analysis was performed by the r&d team on the products returned for the same event and the galling issue was confirmed.Investigation showed that the event was caused by the material of the avantage straight impact plate.A recall was performed on the affected item.Please note that the products in the scope of this recall were not delivered to the usa.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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