EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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Model Number LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/27/2022 |
Event Type
Injury
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Event Description
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As reported by the legal brief, before (b)(6) 2013, patient began medical treatment left knee arthritis.Before (b)(6) 2013, the orthopaedic surgeon indicated that the patient met the criteria for a total knee replacement on his left knee.On or about (b)(6) 2013, surgeon implanted the recalled optetrak components into patient's left knee.On or about (b)(6) 2022, patient underwent surgery to remove the optetrak and replaced it with another implant.On or about (b)(6) 2022, surgeon found that the recalled optetrak polyethylene failed.No other patient/medical information provided.
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Manufacturer Narrative
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Concomitant medical products: logic femoral ps cem left sz 5 (cat# 02-010-01-0250 / serial# (b)(4)).One peg patella 35mm (cat# 200-03-35 / serial# (b)(4)).Lgc tibial fit tray cem sz 5f / 4t (cat# 02-012-45-5040 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Manufacturer Narrative
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(h3) as reported by the legal brief, before on (b)(6) 2013, patient began medical treatment left knee arthritis.Before on (b)(6) 2013, the orthopaedic surgeon indicated that the patient met the criteria for a total knee replacement on his left knee.On or about on (b)(6) 2013, surgeon implanted the recalled optetrak components into patient's left knee.On or about on (b)(6) 2022, patient underwent surgery to remove the optetrak and replaced it with another implant.On or about on (b)(6) 2022, surgeon found that the recalled optetrak polyethylene failed.No other patient/medical information provided.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
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