Model Number N/A |
Device Problems
Corroded (1131); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994)
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Event Date 10/05/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: pn #12-103206, taperloc femoral stem, ln #522830.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports:0001825034-2017-01812; 0001825034-2017-01809;0001825034-2017-01805.
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Event Description
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It is reported by legal counsel for patient reported that patient underwent a left hip revision procedure approximately 5 years post- implantation due to elevated ion levels.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Operative record reported revision due to elevated metal ion levels, squeaking of the implant, osteolysis.Significant foreign body reaction tissue was debrided during the revision.The femoral head, taper and acetabular cup were removed and replaced; a poly liner was implanted.
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Manufacturer Narrative
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This follow up report is being filed to relay corrected and additional information.(b)(4).No devices or photos of the devices were received; therefore, the condition of the components is unknown.Additionally, visual and dimensional evaluations could not be performed.This complaint was determined not to be a new confirmed quality or manufacturing issue.Review of device history records found these units were released to distributor with no deviations or abnormalities.Root cause could not be determined with information available.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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Search Alerts/Recalls
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