MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 13 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 13 MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3.5 years post initial right total knee arthroplasty, the 60 y/o female patient presented to the surgeon¿s office in 2019 with complaints of pain, swelling, and instability.After examination, the patient was scheduled for a revision right tka with a possible poly swap.During that surgery, the poly was removed, and the patient was revised to a crc size 17mm poly.The sales rep was unable to obtain photos or x-rays.The devices are not available for evaluation; discarded by the hospital.No additional information is known to the sales rep.
Additional Manufacturer Narrative
As reported, approximately 3.5 years post initial right total knee arthroplasty, the 60 y/o female patient presented to the surgeon¿s office in 2019 with complaints of pain, swelling, and instability.After examination, the patient was scheduled for a revision right tka with a possible poly swap.During that surgery, the poly was removed, and the patient was revised to a crc size 17mm poly.The sales rep was unable to obtain photos or x-rays.The devices are not available for evaluation; discarded by the hospital.No additional information is known to the sales rep.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 pain, swelling, instability, and subsequent revision cannot be conclusively determined; however, it is most likely patient-related conditions.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
H3: investigation results - the revision reported is most likely the result of instability secondary to changes in soft-tissue function since the time of the initial surgery and/or patient-related issues.However, this cannot be confirmed as the devices were not available for evaluation, and pre-revision radiographs and images of the explanted devices were not provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 13 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15718977
• Report Number: 1038671-2022-01396
• Device Sequence Number: 2873085
• Product Code: JWH
• UDI-Device Identifier: 10885862159236
• UDI-Public: 10885862159236
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2026

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: 08/11/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 13 MM
• Device Catalogue Number: 02-012-49-2513
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 12/27/2023; 07/14/2026
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 01/03/2024; 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2011
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOGIC CR FEMUR RIGHT SZ 2.5 CEMENTED; LOGIC TIBIA FIT TRAY CEM SZ 2.5F/2.5T; THREE PEG PATELLA 32MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 183 LB