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Device Problem
Material Erosion (1214)
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Patient Problems
Encephalopathy (1833); Fall (1848); Fatigue (1849); Bone Fracture(s) (1870); Hearing Impairment (1881); Memory Loss/Impairment (1958); Pain (1994); Visual Impairment (2138); Depression (2361); Sleep Dysfunction (2517); Cognitive Changes (2551)
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Event Date 03/14/2017 |
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 product remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted concomitant medical products: item # unknown/ unknown cup/ /lot # unknown, item # unknown/ unknown neck/ /lot # unknown , item # unknown/unknown stem/ lot # unknown , item # unknown/unknown liner/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -01228, 0001822565 -2020 -01235.
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Event Description
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It was reported that 6 years post left hip implantation patient began experiencing pain and elevated metal ions.Patient reported progressive memory and cognitive problems, worsening of depressive mood disorder, pain tolerance dulling, sleep disorder, fatigue, hearing and vision worsening.No revision has been reported at this time.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) reviewed 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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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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