EXACTECH, INC. EQUINOXE SHOULDER SYSTEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Device Problem
Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10.H3: the revision reported was likely the result of prosthesis wear of the shoulder prosthesis.The cause of prosthesis wear is generally a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.
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Event Description
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It was reported via mw5153297 a patient stated - revision surgeries after polyethylene liner failed in my exactech equinoxe shoulder system.Implant date is (b)(6) 2019 of the reverse shoulder configuration then approximately 4 years, 4 months later on (b)(6) 2023 the patient was surgically revised.The initial reporter [patient] has asked to remain confidential.There is no other information provided/available.
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Search Alerts/Recalls
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