Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00490, 3002806535-2021-00492.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.
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Event Description
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It was reported that a patient underwent an initial knee arthroplasty on an unknown date.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.
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Event Description
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It was reported, that: a patient underwent an initial knee arthroplasty on an unknown date.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.Patient involvement.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.Complaint summary: product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.These devices are used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the devices when they left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided no corrective action required at this time as the root cause of the reported event has not been determined.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00490-1, 3002806535-2021-00492-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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