Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 08/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 tip of the stem extractor fractured during hip revision surgery.Attempts have been made and no additional information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.One exact stem removal jaw was returned and evaluated.Upon visual inspection the device has disassociated between the main body & slap hammer connector.The threaded end was fractured from the rest of the jaw and the threads are mostly sheared off.The device was sent for fracture analysis and the analysis identified the fracture artifacts suggest a tensile overload fracture of the weld & longitudinal shearing of the threads.It is unknown which fracture occurred first and was not able to be determined.The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event.A definitive root cause could not be determined.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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