Catalog Number M5723INT0600220 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that replacement poly inserts (6 mm) have been requested for revision surgery.Reason for revision is unknown at this time.Primary surgery occurred on (b)(6) 2013.Revision surgery is planned for (b)(6) 2021.Review of the device history record indicates that the device was manufactured to specification.All sterilisation requirements were met.
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Event Description
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It was reported that replacement poly inserts (6 mm) have been requested for revision surgery.Reason for revision is unknown at this time.Primary surgery occurred on (b)(6) 2013.Revision surgery is planned for (b)(6) 2021.
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Search Alerts/Recalls
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