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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
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Patient Problems
Host-Tissue Reaction (1297); Fatigue (1849); Memory Loss/Impairment (1958); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Local Reaction (2035); Anxiety (2328); Shaking/Tremors (2515); Sleep Dysfunction (2517); Limited Mobility Of The Implanted Joint (2671)
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Event Date 11/17/2009 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).: item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown liner, lot #: unknown.Item #: unknown , unknown cup, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01108.Reported event was confirmed by maude report.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 was 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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It was reported that a patient underwent a primary tha approximately nine years ago.Currently, the patient is experiencing pain, memory issues, tremors, neuropathy, and elevated metals ions.The patient subsequently underwent a revision of the femoral head.In addition, approximately three months post revision, the patient has exhibited a decrease in the elevated ion levels.Attempts have been made for additional information, however, at the time of this report, no further information is available.
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Search Alerts/Recalls
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