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Catalog Number UNKNOWN DISTAL SCREW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330)
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Event Date 09/29/2021 |
Event Type
Injury
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Event Description
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It was reported in an anonymized retrospective study report, that a patient underwent a revision procedure approximately one (1) year and ten (10) months post-implantation due to soft tissue irritation.Due diligence is complete as multiple attempts were made; however, no further information is available.As no additional information or product is available, we are unable to provide further information.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01768.Concomitant medical products: item# unknown distal screw; lot# unknown.Report source: foreign - event occurred in united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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Search Alerts/Recalls
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