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Model Number N/A |
Device Problems
Detachment Of Device Component (1104); Naturally Worn (2988)
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Patient Problem
No Code Available (3191)
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Event Date 03/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00620204822, trabecular metal modular cup, 62283425, 00877503201, bioloxâ® delta ceramic femoral head, 2678778.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 02278.Requested but not returned by hospital.
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Event Description
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It was reported that a patient underwent an initial left hip procedure.Subsequently, the patient was revised due to wear.A portion of the shell above the locking ring tabs was found broken.This allowed the liner to move, and some of the elevated portion of the liner was broken as well.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Additional: updated reported event was confirmed by review of x-rays provided.X-ray review; no fracture can be identified, as no displaced fracture is identified.If there is a nondisplaced fracture, this cannot be excluded.Minimal eccentric positioning of the left femoral head with respect to the cup can be seen in the setting of liner malfunction, as suggested in the provided complaint.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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