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Model Number N/A |
Device Problems
Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Pain (1994); Scar Tissue (2060); Osteolysis (2377); Metal Related Pathology (4530)
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Event Date 02/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2022-00563, 0001825034-2022-00565, 0001825034-2022-00569.
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Event Description
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It was reported that the patient underwent a revision procedure approximately 11 years post implantation due to pain, elevated metal ions, aseptic loosening, metallosis, bone loss and scar tissue.Attempts have been made and additional information on the reported event is unavailable at this time.
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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 information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: left hip aseptic loosening.Pain and elevated metal ion levels.Extensive metallosis noted within hip.No destruction to trunnion, stem well fixed and remained implanted.Noted in acetabulum once cup removed, scar tissue, extensive bone loss in the anterior, posterior, and medial walls all associated with advanced metallosis.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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Search Alerts/Recalls
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