MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 3, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic cr femoral cem right sz 3, cat#: 02-010-03-0330, serial#: (b)(4), lgc tibial fit tray cem sz 3f/3t, cat#: 02-012-45-3030, serial#: (b)(4), three peg patella 35mm, cat#: 200-02-35, serial#: (b)(4).(as reported by the legal brief, on or about (b)(6) 2012, patient underwent a right total knee arthroplasty due to osteoarthritis in his right knee.Subsequently, on or about (b)(6) 2020, the patient underwent a right knee revision due to a failed right total knee arthroplasty.Following the revision surgeries, the patient "continues to be limited in his activities of daily living, and experiences daily pain and discomfort in both his left and rights knees." 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 subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Event or Problem Description
As reported by the legal brief, on or about (b)(6) 2012, patient underwent a right total knee arthroplasty due to osteoarthritis in his right knee.Subsequently, on or about (b)(6) 2020, the patient underwent a right knee revision due to a failed right total knee arthroplasty.Following the revision surgeries, the patient "continues to be limited in his activities of daily living, and experiences daily pain and discomfort in both his left and rights knees.".
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d8, e4 (remove erroneous entry from initial report), g2, h6: clinical codes, medical device problem code, component code, investigation conclusion.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Report #1 of 2 for this event.As reported by the legal brief, this patient underwent a right total knee arthroplasty.Subsequently, eight (8) years later the patient experienced daily pain and discomfort.As a result, the patient underwent a right knee revision.Additionally, it was reported, following the right knee revision, the patient continues to experience significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss and other injuries presently undiagnosed.No additional information is available.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 3, 11MM
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15720278
• Report Number: 1038671-2022-01398
• Device Sequence Number: 7542722
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2026

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: 07/29/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 3, 11MM
• Device Catalogue Number: 02-012-49-3011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 03/26/2026; 07/10/2026
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 04/13/2026; 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male