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Model Number N/A |
Device Problem
Corroded (1131)
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Patient Problems
Memory Loss/Impairment (1958); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Sleep Dysfunction (2517)
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Event Date 09/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part # unknown/ unknown head / lot # unknown, part #unknown / unknown liner/ lot # unknown, part # unknown/ unknown cup/ lot # unknown, part # unknown/ unknown stem/ lot #unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -01605.0001825034 -2020 -01608.
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Event Description
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It was reported patient underwent a revision procedure approximately 2 years post implantation due to elevated metal ions, pain, peripheral neuropathy memory and balance issues, fatigue, sleep disturbances, positive pet scan for chronic toxic encephalopathy and ct scan for fluid at right hip.It was noted that during the revision, cloudy fluid, metallic staining, corrosion of head/trunnion, tissue had appearance of altr and fish flesh appearance.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.The following sections were updated/corrected updated: g4; h2; h3; h6 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause is unable to be determined as the necessary information to adequately investigate the reported event was not provided 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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