ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 8MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number UNIVERS APEX HUMERAL STEM, 8MM |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Pain (1994); Discomfort (2330); Joint Laxity (4526)
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Event Date 11/11/2021 |
Event Type
Injury
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Event Description
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On 11/19/2021, it was reported by a sales representative via email that an ar-9100-08s humeral stem and ar-9154-21p humeral head were originally implanted on (b)(6) 2019.The glenoid aspect of the surgery seemed fine both during pre-op assessment as well as intra-op.About a year and a half after implantation, patient began to experience pain and discomfort, it looked as if the stem had subsided and it was loose.During the revision surgery on (b)(6)2021, samples were taken from both the joint space and canal area.All tests came back negative for infection, which leads to the issue being aseptic loosening.Once the stem was removed there was no bony on or ingrowth in the implant.Surgeon was able to replace both humeral stem and humeral head with an ar-9501-10p revers humeral stem, an ar-9501-fx10n revers fracture adapter, and an ar-9150-19p univers humeral head.
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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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