ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 125°, RIGHT, ø 10 MM, 21.5 CM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Date 06/30/2022 |
Event Type
Injury
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Event Description
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It was reported that approximately 9 months after implantation, the patient felt severe pain in hip, without any prior trauma.Further investigation has shown that implant is fractured and patient has to be revised.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).Report source: foreign- france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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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 and/or corrected information.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 further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The complained cephalomedullary nail as well as the lag screw and two cortical screws were provided to the product surveillance team for further investigation or review.The nail has fractured in half at the bore hole meant for the insertion of the lag screw.There are multiple scratch marks present at and around the site of fracture, likely stemming from the device extraction, as well as polished surfaces within the distal bore holes of the nail.The fracture surface of the proximal part is damaged and covered with multiple scratches and polished surfaces on one side.On the other side, no signs of beach lines can be observed.The tip of the setting screw in the bore hole is notably damaged.The fracture surface of the distal part does not show any signs of beach lines as well.The type of fracture can therefore not be determined.The lag screw shows multiple scratches around the distal part, where contact with the setting screw is made.Both cortical screws show signs of damage at the threaded area.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.One materiovigilance report was received dated jun 30, 2022.Indication for surgery was a nail fracture 9 months post-implantation without any trauma.Of note is that the report is mentioning the left leg as being the affected leg.However, the implanted product is a right nail.Additionally, it is mentioned in the report that the scratches seen on the nail are due to its extraction.No further medical documents such as surgical reports, x-rays or office visit notes were provided.The investigation did not identify a nonconformance or a complaint out of box (coob).A definitive root cause cannot be determined.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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