Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 07/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign source: (b)(6).Customer has indicated that part of 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.
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Event Description
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It was reported that patient underwent left total knee arthroplasty.During the procedure, as the surgeon was trying to remove the pin from the femoral cut guide, the pin fractured.A portion of the fractured pin remained in the patient's bone.The surgeon elected to leave the fragment in the bone.No additional patient consequences were reported.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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.
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Search Alerts/Recalls
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