Model Number N/A |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
Pain (1994)
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Event Date 11/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products - product - unknown recap shell, therapy date - (b)(6) 2016.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported by the patient's legal representative that the patient underwent an initial right hip arthroplasty.Subsequently, a revision procedure was performed due to pain and elevated metal ion levels.
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Manufacturer Narrative
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(b)(4).The 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.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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Search Alerts/Recalls
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