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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
Ossification (1428); Pain (1994); Scar Tissue (2060); Synovitis (2094); Reaction (2414)
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Event Date 08/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: biomet m2a-magnum pf cup 58odx52id cat#us157858 lot#152030; biomet m2a-magnum mod hd sz 52mm cat#157452 lot#617100; biomet taperloc micro lat fmrl 11mm cat#15-103205 lot#635750; biomet m2a-magnum 52-60mm tpr insrt-3 cat#139266 lot#198660.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 - 2020 - 03528, 0001825034 - 2020 - 03529, 0001825034 - 2020 - 03530.
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Event Description
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It was reported the patient had an initial right tha.Subsequently, the patient was revised approximately 9 years later due to pain, synovitis, scar tissue, and bone remodeling (sclerotic bone).It was noted that fifteen minutes was spent trying to remove the femoral head as it appeared to be cold-welded.The surgeon went to the backup plan and removed the entire stem.The head, liner, cup and stem were removed and replaced.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/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: painful rtha with metal-on-metal articulation.Extensive synovitis around hip.Significant metal fusion of the femoral head onto the femoral stem with inability to remove requiring greater trochanteric osteotomy with complete conversion of the right femoral stem.Significant right hip and knee pain.Limitations of activity due to pain.Multiple exams including images indicate possible femoral stem loosening along with questionable reaction to metal-on-metal sensitivity.Fifteen minutes was spent trying to remove the femoral head as it appeared to be coldwelded.The surgeon went to the backup plane and removed the entire stem.There was no significant looseness of the femoral stem.Femoral stem removed without significant bone loss.Significant sclerotic bone at the very distal aspect of the femoral stem which was removed.Significant scar tissue around the sciatic nerve.Good rom and stability with final products.No intra-operative complications noted.A review of the device history records identified no deviations or anomalies during manufacturing.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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Search Alerts/Recalls
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