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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Bone Fracture(s) (1870); Failure of Implant (1924); Osteolysis (2377); Metal Related Pathology (4530)
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Event Date 11/07/2019 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision procedure of the left hip approximately eleven (11) years post implantation due to metallosis, osteolysis, pseudotumor, and a trochanteric fracture.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog#: 157446 m2a-magnum mod hd sz 46mm lot#: 908140, catalog#: us157852 m2a-magnum pf cup 52odx46id lot#: 496100, catalog#: 139259 m2a magnum 42-50m tpr insrt +6 lot#: 036980.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: 0001825034-2022-00704, 0001825034-2022-00705, 0001825034-2022-00706.
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Manufacturer Narrative
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H6: component code: mechanical (g04) - stem.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: metallosis with pseudotumor, chronic trochanteric fracture left hip, severe osteolysis of the proximal femur and acetabulum, damaged femoral trunnion.Unable to dislodge the female side of the trunnion, stem removed with burs and osteotomes, significant defects noted.Shell grossly loose, severe osteolytic defects behind the cup, packed with bone graft.Bone soft and osteopenic.Chronic defect of his trochanter with eroded bone and chronic fibrous nonunion of his trochanteric fracture, secured with cerclage cables.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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Event Description
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It was reported that the patient underwent a revision procedure of the left hip approximately eleven 11 years post implantation due to metallosis, osteolysis, pseudotumor, and a trochanteric fracture.During the revision, the shell was found grossly loose, the trunnion was cold welded, and multiple bony defects in the femur and acetabulum were encountered.The eroded and non-unionized trochanteric fracture was repaired with cerclage cables.All implants were replaced with competitor product.No further event information available at the time of this report.
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Search Alerts/Recalls
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