Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/07/2023 |
Event Type
Injury
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Event Description
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It was reported a patient underwent an initial hip arthroplasty that was subsequently revised due to poly wear.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown cup.Unknown stem.Unknown head.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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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 {update/corrected}.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.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 information at the time of this report.
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Search Alerts/Recalls
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