(b)(4) report source: foreign: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00071.
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This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).The following sections were updated/corrected updated: b4, b5, g4, g7, h2, h3, h6, h10 the reported products were reviewed for compatibility and it was determined that the combination of femoral stem and femoral head utilized is not compatible.Dhr was reviewed and no discrepancies relevant to the reported event were found.Per the ifu for the free constrained liner system, use biomet® femoral and freedom¿ modular head component with appropriate matching type i taper or 12/14 taper.Additionally, the product's label mentions the legal manufacturer of the product to help the user distingush between biomet and zimmer products.Therefore, the root cause can be attributed to use error.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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