EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
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Model Number LOGIC TIBIA PS MOD INSRT SZ 5 11MM |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/27/2023 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: serial #: (b)(4), catalog #: 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t; serial #: (b)(4), catalog #: 200-02-38 - three peg patella 38mm; serial #: (b)(4), catalog #: 02-010-01-0250 - logic femoral ps cem left sz 5.Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Event Description
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It was reported via a legal notification that a male patient, initial left knee implanted on (b)(6) 2015, presented to their joint replacement institute for reasons unknown.Examination was performed and x-rays were taken.It was determined that the plaintiffs optetrak® device is failing at a much faster rate than expected making the artificial knee joint more prone to wearing out, loosening, and causing pain, muscle, nerve, and bone damage.This also significantly increases the likelihood that the joint will break.The plaintiff's surgeon recommended revision surgery to remove and replace the optetrak® device.
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Manufacturer Narrative
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H6: investigation results: the reason for the pain and ultimate revision cannot be determined, but may be related to the inclusion of the implanted polyethylene in the packaging recall.Based on the provided information, it does not appear to be related to prosthesis wear.However, this cannot be confirmed as the devices are not available for evaluation and additional first-hand details were not provided.
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Event Description
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Additional information- it was reported that the patient had a revision of the left knee on (b)(6) 2023.The patient complained of pain and had a recalled poly.Devices not returning, due to recall hospital will not release.Patient was last known to be in stable condition following the event.X-ray and image were received.There is no other information available.
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Manufacturer Narrative
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Additional/updated information ¿ a2, b3, b5, b7, d6b, h6 health effect - clinical code, health effect - impact code, medical device problem code.These devices are used for treatment not diagnosis.There is no other information available.
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Search Alerts/Recalls
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