EXACTECH, INC. CONNEXION GXL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/23/2023 |
Event Type
Injury
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Event Description
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As reported via legal documentation, a patient had left hip replacement surgery on (b)(6) 2015.They underwent left hip revision surgery on (b)(6) 2022, approximately 6 years 10 months post primary procedure.Patient claims to have suffered extreme pain, instability and revision surgery as a result of this device.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, (b)(4), and pending in the eastern district of new york.Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.
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Manufacturer Narrative
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Additional information including investigation results shall be provided within 30 days of receipt.
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Manufacturer Narrative
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The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.
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