(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4) event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 04446, 0001822565 - 2018 - 04447, 0001822565 - 2018 - 04448, 0001822565 - 2018 - 04449, 0001822565 - 2018 - 04450, 0001822565 - 2018 - 04451, 0001822565 - 2018 - 04452, 0001822565 - 2018 - 04453, 0001822565 - 2018 - 04455, 0001822565 - 2018 - 04456, 0001822565 - 2018 - 04457, 0001822565 - 2018 - 04458, 0001822565 - 2018 - 04459, 0001822565 - 2018 - 04460, 0001822565 - 2018 - 04461, 0001822565 - 2018 - 04463, 0001822565 - 2018 - 04464, 0001822565 - 2018 - 04465, 0001822565 - 2018 - 04466, 0001822565 - 2018 - 04467.
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It was reported that during incoming inspection at the warehouse, there was a stain found on the product.There were no adverse events as a result of this malfunction, as there was no patient involvement.Attempts have been made and no further information has been provided.
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