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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Swelling (2091); Tissue Damage (2104); Reaction (2414); Ambulation Difficulties (2544)
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Event Date 09/26/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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: mri positive and cobalt chromium both elevated cobalt level 139.2 & chromium level 133.8 tissue stained dark grey, and avascular was noted to some of the tissue revision records: surgeon notes large osteolysis, and soft tissue damage as well as acetabular fractures prior to revision.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08590.0001825034 - 2020 - 03672.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 patient underwent total hip arthroplasty approximately 14 years ago.Patient underwent revision 10 years post implantation due to patient complaint of metallosis, tissue death, bone damage, lack of mobility, inflammation, metal poisoning.No further event information available at the time of this report.
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Search Alerts/Recalls
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