Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 09/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: us157858 m2a cup 019350; 139270 m2a taper insert 898350; item #: unknown unknown stem lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03764, 0001825034 - 2020 - 03765.
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Event Description
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It was reported that the patient underwent an initial hip arthroplasty.Subsequently, the patient's magnum mom was revised to a dual mobility over ten years later due to unknown reasons.No additional information is available.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.An xray was provided and reviewed by a healthcare professional.Right hip arthroplasty components are anatomically aligned.There is no fracture, dislocation or other abnormality.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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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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