Model Number N/A |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Information (3190)
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Event Date 04/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown-unk head-unknown; unknown-unk stem-unknown; unknown-unk cup-unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, hospital discarded device.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Discareded by hospital.
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Event Description
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It was reported the patient underwent a revision surgery approximately 30 years post implantation due to liner wear.During the procedure the head and liner were revised.There were no complications or patient harm.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 confirmed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: marked eccentric position of the left femoral head reflecting advanced liner wear as noted.No further evaluation could be performed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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 additional information on reported event.
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Search Alerts/Recalls
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