ARTHREX, INC. REVERS 36MM CA ADAPTER ASSEMBLY; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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Model Number REVERS 36MM CA ADAPTER ASSEMBLY |
Device Problem
Failure to Advance (2524)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/16/2021 |
Event Type
malfunction
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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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On (b)(6) 2021, it was reported by sales representative via phone that ar-9502-36arca revers 36mm ca adapter assembly (line #1) would not engage with the ar-9544-17rca revers 36mm ca adapter assembly(line # 2) the surgeon could not achieve the desired stability.A second ar-9502-36arca (line #3) was opened and the same issue occurred.The case was completed using the universal 2 stem and head system without issue.The case was delayed 45 minutes.Additional information 8/2/2021: per the sales representative, the case was on (b)(6).No additional anesthesia was required to complete the case.
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Manufacturer Narrative
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Complaint not confirmed, the devices were found to fit with each other's properly.Cmm measurement of the taperlock features did not reveal any abnormality.
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Search Alerts/Recalls
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