EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
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Catalog Number 02-012-44-5011 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Osteolysis (2377)
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Event Date 03/04/2022 |
Event Type
Injury
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Manufacturer Narrative
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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 with an optetrak logic ps tibial insert, size 5, 11mm on (b)(6) 2015, underwent a revision procedure on (b)(6) 2022, approximately 7 years 1 month post the initial procedure.During the revision surgery, a substantial amount of osteolysis and implant loosening was noted.Upon information and belief, the loose components and osteolysis in plaintiff¿s left knee was due to premature polyethylene wear of the tibial insert.Following the revision surgery, plaintiff continues to be limited in his activities of daily living.Plaintiff has difficulty with daily activities such as getting dressed, climbing stairs, and bathing.Despite undergoing the revision surgery, the plaintiff experiences daily pain and discomfort in his knee which limits his activities of daily living and impacts his quality of life.No device return anticipated due to this being a legal case.No further information.
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Manufacturer Narrative
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Additional information - e3, e4.H6.Investigation results - the revision reported may have been due loosening, osteolysis, and polyethylene wear.The loosening/osteolysis may have been the result of an insufficient bond between the knee components and the bones.The root cause of the reported wear cannot be determined as the explanted devices were not returned for evaluation and images of the explanted device/radiographs were unable to be obtained.These devices are used for treatment not diagnosis.There is no other information available.Correction-e1 -facility name.
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Manufacturer Narrative
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Product has been identified.As a result, the following fields have been updated: d1, d4, h4, h7, and h9.Any additional information and/or investigation results will be provided within 30 days of receipt.
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Search Alerts/Recalls
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