Device Problem
Naturally Worn (2988)
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Patient Problem
No Information (3190)
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Event Date 05/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.Reported event was unable to be confirmed due to limited information received from the customer.Radiographs identified left total hip arthroplasty with polyethylene wear of the acetabular cup.No further evaluation was possible using the x-ray image provided.Device history record (dhr) reviewed was unable to be performed as the lot number of the device involved in the event is unknown.Root cause is 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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Event Description
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It was reported patient had hip surgery approximately 30 years ago.Subsequently patient has been indicated for revision surgery due to unknown reasons.Radiograph review indicates the patient is experiencing liner wear; however, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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It was reported that patient was revised approximately one month ago.During the revision procedure the cup, head and liner were removed and replaced.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.
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Search Alerts/Recalls
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