Model Number N/A |
Device Problem
Corroded (1131)
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Patient Problems
Pain (1994); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)
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Event Date 01/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown liner, unknown cup, unknown head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02486.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.
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Event Description
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It was reported that the patient was revised due to pain, stiffness and cobalt poisoning approximately 8 years post implantation.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 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.Device not returned for evaluation.
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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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