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Model Number ECLIPSE CAGE SCREW M, 35MM |
Device Problem
Biocompatibility (2886)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 02/06/2024 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that a revision of an eclipse with universal glenoid was necessary due to wear of the polyethylene glenoid of the universal glenoid base plate.It was further reported that the issue cause a strong metallosis due to the metal to metal friction.The following devices were explanted during the revision surgery: cd-9341-16 eclipse head, size 41/16 tinbn coated.Ar-9300-41cpc eclipse trunion,41 mm tps ctd.Ar-9301-02 eclipse cage screw m, 35mm.Ar-9120-01 universal glenoid - baseplate small.Ar-9165-20 universal glenoid - central screw 20mm.2x unknown peripheral screws.
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Search Alerts/Recalls
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