Model Number UNIVERSAL GLENOID - CENTRAL SCREW 15MM |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/20/2020 |
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.
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Event Description
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It was reported that on (b)(6) 2019 a revers shoulder arthroplasty was performed.Everything went well and it was finished successfully.The surgeon was satisfied after the case.This was also showed on the x-rays.Approximately 6 months post-op the patient reported subsequently failing while putting on trousers.He felt an issue.This was when the glenoid side gave way.It was an elective revers and not a fracture revers.X-rays were done on (b)(6) 2020.A revision surgery is planned to be on (b)(6) 2020.Update 02-apr-2020: further information was received: the revision surgery went ahead on (b)(6) 2020 afternoon.It was revised with the new modular glenoid system, successfully using an iliac crest graft.Everything went very well.The failed devices were retrieved, however both peripheral screws were broken and the tips remain in the patient.Baseplate, central screw & remaining portion of peripheral screws x 2 will be returned assembled.Also from the humeral side the cup and liner, which needed to be removed for access, will be returned.There was no issue with the humeral side, however they will be returned regardless.
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Manufacturer Narrative
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Complaint not confirmed, no abnormality was observed on the device that may have contributed to the event.The most likely cause of the event and angled position of the screw is fall/trauma, as stated in the event description.Additional information provided has been added to section b.
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Event Description
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Follow-up update on (b)(6) 2020 : further information was provided that the patient was elderly and the bone quality was not in top condition but also not too bad.The damage to the implants occurred (as the patient claims) when putting on trousers, this necessitated the revision, they did not break on removal, they were already broken from whatever trauma they suffered.It was further reported that it is very unlikely that just putting on trousers caused both screws to break.
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Search Alerts/Recalls
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