(b)(4).D10 - medical product: catalog #: unknown, humeral tray, lot # unknown.G2: uk.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02614.
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(b)(4).D10 - medical product: catalog #: unknown, humeral tray, lot # unknown; catalog #: unknown, stem, lot # unknown; catalog #: unknown, baseplate, lot # unknown; catalog #: unknown, screw, lot # unknown x 5.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02614, 0001822565-2023-03088, 0001822565-2023-03089, 0001822565-2023-03090, 0001822565-2023-03091, 0001822565-2023-03092, 0001822565-2023-03093, 0001822565-2023-03094.
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(b)(4).D10 - medical product: catalog #: unknown, head, lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03415.
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