Model Number N/A |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 09/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Report source foreign country: germany.An investigation into this incident is currently underway.Once the investigation has been completed and the results are made available, a follow up mdr will be submitted.Part of device remains in patient.
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Event Description
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It was reported that the tip of the pin, which is used to attach the femoral navitracker, remained in the patient's femur.Attempts are being made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed via x-ray images provided and reviewed by a health care professional.Review confirmed the presence of a nonspecific triangular-shaped hypodense structure in the bone.No contributing factors from the bone were detected.Dhr review could not be performed as the serial and/or lot numbers for the product could not be identified.The definitive root cause could not be determined based on the information available.Potential contributing factors may include excessive force applied during insertion or removal.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.H3 other text : device was discarded.
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Event Description
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No additional information on the reported event.
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Search Alerts/Recalls
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