Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)
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Event Date 12/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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Cmp (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00014 delano lag screw item #: 814510105 lot #: ug1111305d delano a/r screw item #: 814501090 lot #: dnccm1 foreign - event occurred in (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.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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Event Description
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It was reported patient underwent revision approximately four (4) months ago post implantation due to non-union of the fracture and fracturing of the nail and lag screw.It was reported approximately three (3) weeks ago patient underwent revision.During procedure, components were removed and replaced.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.No alleged problem or complaint was made against this device.Reporter stated they were just providing all the implanted devices.No problem was found with the returned device, and no findings against the lag screw was noted in the x-ray.The initial report was forwarded in error and should be voided.
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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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Search Alerts/Recalls
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