MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 2.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-2509
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Scar Tissue (2060); Synovitis (2094); Insufficient Information (4580)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 66 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
Based on additional information received, the following fields were updated: a2, b5, d1, d4, g2, g4, h4, h6.Pending investigation including additional information received.Concomitant devices: (b)(6), 02-010-03-0225 - logic cr femoral cem, left sz 2.5; (b)(6), 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t; (b)(6), 200-02-35 - three peg patella 35mm.
Event or Problem Description
Additional information received: pre-op and post-op diagnoses indicated mechanical failure left knee replacement secondary to recall.During revision, it was found that there was grossly delaminated polyethylene with fracturing of the plastic itself particularly medially.Free-floating fragments within the knee joint.A complete synovectomy was performed and sent for culture.The tibial insert was removed and demonstrated substantial delamination and fragmentation of the medial side with essentially pieces missing.There was no metal-on-metal contact nor was there evidence of metallosis within the joint itself.There did not appear to be any gross plastic changes present on the patellar button, but the patella seemed perhaps to be slightly maltracking.A new patellar cut was made, taking up a bit more medial bone and then medialized a smaller patella button to 32mm.The trial button was placed and then placed a trial 9mm insert and checked stability.The knee was perhaps just slightly shy of full extension and a bit tight laterally.Lateral scar tissue was freed up getting a more satisfactory extension endpoint and also a bit more stability to the medial side.There were no complications.The patient was awoken from anesthesia and transferred to the pacu in stable condition.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, fracture and patella tracking or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.H6: corrected health effect, medical device and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT SLOPE +, SZ 2.5, 9 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20030152
• Report Number: 1038671-2024-02969
• Device Sequence Number: 15294760
• Product Code: JWH
• UDI-Device Identifier: 10885862159182
• UDI-Public: 10885862159182
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2021
• Device Catalogue Number: 02-012-48-2509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 04/08/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/15/2024; 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female