Catalog Number M5723INT0600210 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/24/2021 |
Event Type
Injury
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Event Description
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It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is laxity.Primary surgery occurred on (b)(6) 2015.Revision surgery is planned for (b)(6) 2022.
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Manufacturer Narrative
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It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is laxity.Primary surgery occurred on (b)(6) 2015.Revision surgery is planned for (b)(6) 2022.Review of the device history record indicates that the device was manufactured to specification.All sterilisation requirements were met.
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Search Alerts/Recalls
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