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Catalog Number 118001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
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Event Date 07/13/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a revision procedure approximately 2.5 years post implantation due to disassociation of the glenoid and metal post.During the revision, found the stem with significant metallosis type of debris around it, resorption noted around the neck of the humerus and the calcar, synovitis resulting in a complete synovectomy, a piece of the polyethylene baseplate that fractured off and was left attached to the ingrowth post, wear to the glenoid, and significant glenoid damage with posterior erosion and a b2 type of configuration.All components were removed without complication and competitor product was implanted.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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(b)(4).Concomitant medical products: sm hybrid glenoid base 4mm cat# 113952 lot#676850; pt hybrid glen post regenerex cat# pt-113950 lot#757630; comp primary stem 10mm micro cat# 113610 lot# 178990; versa-dial 42x21x43 hum head cat# 113034 lot# 807310.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01733; 0001825034 - 2022 - 01734; 0001825034 - 2022 - 02699; 0001825034 - 2022 - 02701.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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