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Model Number N/A |
Device Problems
Corroded (1131); Patient Device Interaction Problem (4001)
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Patient Problems
Ossification (1428); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
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Event Date 03/10/2020 |
Event Type
Injury
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Event Description
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It was reported the patient underwent a right hip revision approximately 14 years post implantation due to pain and elevated metal ions.During the revision metal on metal at the ball/socket as well as trunnionosis, small pseudotumor, aseptic loosening of the trunnion and acetabular component with no bone growth on posterior surface, and breach to bone in the acetabulum.The head and cup were exchanged without complications.The stem remained implanted.No additional information.
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Manufacturer Narrative
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(b)(4).Concomitant products: cat#us157848 m2a-magnum pf cup 48odx42id; cat#157442 m2a-magnum mod hd sz 42mm; cat#11-103206 taperloc por lat fmrl 12.5x145.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: 0001825034 - 2022 - 00786, 0001825034 - 2022 - 00787 , 0001825034 - 2022 - 00788.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: had a late dislocation of mom tha a few years ago with closed reduction, no surgery required.Right hip metal on metal failure, metal on metal at the ball/socket as well as trunnionosis, small pseudotumor, aseptic loosening of the acetabular component.Pain and elevated metal ions, small wall breach to bone in the acetabulum.Trunnion found to be unstable, stem found stable, acetabulum unstable with no bone on the posterior surface.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot 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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