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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
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Patient Problems
Ossification (1428); Necrosis (1971); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
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Event Date 05/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: m/l taper femoral stem (00-7711-010-00, 62059159).Versys femoral head +0 (00-8018-032-02, 62091865).Trilogy acetabular shell (65-6200-050-22, 62049516).Trilogy acetabular liner (00-6305-050-32, 60999098).Bone screw (00-6250-065-25, 62136805).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00014, 0002648920-2021-00013.
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Event Description
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It was reported that patient underwent a right total hip arthroplasty.Subsequently, patient underwent a revision procedure approximately 7 years later due to elevated metal ion levels, pain, ho, tissue damage, synovitis/bursitis, implant wear, scar tissue, necrosis, and invivo corrosion.The head and liner were revised.No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records were provided and reviewed by a healthcare professional.Patient underwent a right tha due to oa; no intraoperative complication noted.Patient was revised due to elevated metal ions, pain, ho, tissue damage, synovitis/bursitis, implant wear, scar tissue, necrosis, and invivo corrosion.Labs confirmed elevated cobalt levels of 7.5, chromium levels were less than 0.1mcg/l.Revision operative notes identified persistent right hip pain.Right hip synovitis and acetabular liner wear.There was wear debris in the posterior aspect anterior-superior and inferior circumferentially around the liner.There was hypertrophic tissue overlying the trochanter and evidence of partial tearing of the abductors.There was impressive bursal inflammation and debris that was debrided back to a stable base.No fluid collection or obvious mass in thigh.There was mild metallosis at the femoral head neck junction.No obvious metallosis.Fibro-adipose tissue with necrosis and focal perivascular lymphocytic infiltrates consistent with aseptic lymphocyte vasculitis-associated lesion.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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