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Catalog Number 9999 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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Pending investigation.
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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 7 years post primary procedure.They have reported having suffered from extreme pain, instability, dislocations, and a revision surgery as a result of this exactech device.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, 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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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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Search Alerts/Recalls
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