MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty (tka) on the left side.Subsequently, the patient experienced pain and swelling.As a result, the patient was revised.Upon revision it was found that the tibial implant seemed to be delaminating and worn specifically on the medial posterior aspect of the implant.The three-peg patella didn't appear to show signs of much deformation or delamination but was removed since it was a recalled implant.The womb was debrided and a large void was noticed in the distal femur where the im rod was placed in the initial tka, likely due to osteolysis.The void was debrided and filled with abx bone cement.The surgeon revised the tibial liner and the three peg patella and replaced the implants with activit-e truliant implants.Patient was last known to be in stable condition following the event.No further information is available.
Additional Manufacturer Narrative
D10: 02-010-04-0240 - logic cr femoral por, left, sz 4; (b)(6).02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t; (b)(6).13a2101 - cemex system fast genta 70g; (b)(6).200-02-35 - three peg patella 35mm; (b)(6).201-78-15 - holding pin mini sharp point 4 pk; (b)(6).201-78-81 - 3" trocar, mod.Hex 2pk; (b)(6).201-78-81 - 3" trocar, mod.Hex 2pk; (b)(6).203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19; (b)(6).Product has been received by exactech and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24249220
• Report Number: 1038671-2026-00114
• Device Sequence Number: 12848534
• Product Code: JWH
• UDI-Device Identifier: 10885862174536
• UDI-Public: 10885862174536
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: 12/07/2020
• Device Catalogue Number: 02-012-49-4013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2013
• 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: 70 YR
• Patient Sex: Male