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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Event Description
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Update dw 08-mar-2024: further information were provided that the devices were initially implanted in 2016.Update dw 28-mar-2024: further information were provided that the initial surgery was performed on (b)(6) 2017.
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Manufacturer Narrative
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Complaint allegation is confirmed based on the photos provided by the customer.Visual evaluation revealed an explanted peripheral screw (pn unknown).In addition, a photo of the metallosis was also provided.The head, tinbn, is an inferior bearing surface than the standard cobalt chrome.Likely done due to the patient having a nickel allergy.This bearing surface may have contributed to wearing the poly more quickly.The most likely cause for the reported failure can be attributed to a patient-specific event.
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Search Alerts/Recalls
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