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 10/23/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: 32833305500 item name centralizer for use with cpt femoral stems lot#: 64590498.00801102016 item name: allen medullary cement plugs 1-16 mm diameter flange/8 mm.Diameter core store in cool dry place lot#: 64627151.010000700 item name: g7 bonemaster ltd acet shl46b lot#: 6774556.010000846 item name: g7 neutral e1 liner 32mm b lot#: 6731115.00801803202 item name: femoral head sterile product do not resterilize 12/14 taper lot#: 64800716.G2: foreign: australia.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text: device remains implanted.
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Event Description
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It was reported that the patient underwent a revision procedure 2 years post implantation due to periprosthetic fracture.The patient had a fall which caused the fracture.Cerclage cables have also been placed.There is no additional information available at the time of this report.
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Event Description
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There is no update to the prior event description provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6 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 record 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: periprosthetic fracture of the proximal right femur with suspected implant subsidence it was reported the patient fractured their femur due to a fall, however 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.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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