Model Number N/A |
Device Problems
Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907); Naturally Worn (2988)
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Patient Problems
Patient Problem/Medical Problem (2688); No Information (3190)
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Event Date 04/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign: europe: (b)(6).Concomitant medical products: item# 32810506301, lot# 60785804, interchangeable ulnar assembly.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.
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Event Description
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It was reported that the patient was implanted with prosthesis on (b)(6) 2009 for complex fracture.Subsequently, following a trauma attack, the patient was revised due to metallosis, polyethylene wear and known decoupling on (b)(6) 2019.No additional patient consequences were reported.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: 0001822565-2019-02218.
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Event Description
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It was reported that the patient underwent initial procedure for complex fracture.Subsequently, following a trauma attack, the patient was revised due to metallosis, polyethylene wear and known decoupling.No additional patient consequences were reported.
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Search Alerts/Recalls
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