MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 11 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-2511
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 8 years post the initial left total knee arthroplasty, the patient presented back to the surgeon's office with concerns of a recalled implant, along with pain, instability, and dissatisfaction.The insert was revised to a new insert.Posterior aspects of the polyethylene was broken in pieces, and the pieces of polyethylene were removed.The knee joint was irrigated well.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: 4601034, 02-010-03-0225 - logic cr femoral cem, left sz 2.5.4664685, 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t.4753149, 200-02-29 - three peg patella 29mm.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear and instability, which ultimately led to device fracture.Possible causes for polyethylene wear include high contact stresses during knee flexion, third body wear, instability, or due to the inclusion of the polyethylene in the packaging recall.The instability may have occurred because of the posterior articulation of the femoral component on the insert, or the posterior wear may have resulted in instability.However, the series of events cannot be confirmed as the devices were not available for evaluation.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 11 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21967793
• Report Number: 1038671-2025-01975
• Device Sequence Number: 18315781
• Product Code: JWH
• UDI-Device Identifier: 10885862159229
• UDI-Public: 10885862159229
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: 02-012-49-2511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2013
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female