(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 supplemental mdr will be submitted.Concomitant medical products: medical product: unknown tibial component, catalog #: unknown, lot #: unknown, medical product: unknown bearing, catalog #: unknown lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00020 3002806535-2020-00019.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
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(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, h1, h2, h3, h6, h10 multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00019-1 3002806535-2020-00020-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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