Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870)
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Event Date 03/27/2024 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D1: femoral stem 12/14 neck taper extra ext.Offset size 2 130 mm stem length packaged with standard centralizer.G2: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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 the patient suffered a periprosthetic fracture from a fall five (5) weeks post operative.The surgical technique of the product was utilized, and the implant did not contribute to the fall.The stem remains stable and was not revised.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04)- stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: oblique displaced fracture of the left femur near the tip of the femoral implant as noted it was reported the patient suffered a periprosthetic fracture due to a fall.As the reason for the fall is unknown, a definitive root cause cannot be determined.This complaint was confirmed based on the provided x-rays confirming the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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