MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 1, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-1011
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-010-03-0310 - logic cr femoral cem, right, sz 1: (b)(6), 02-012-45-1010 - lgc tibial fit tray cem sz 1f / 1t: (b)(6), 200-02-32 - three peg patella 32mm: (b)(6), 204-34-04 - fluted stem extension 40l x 14 mm: (b)(6), 204-70-00 - tibial stem ext.Screw: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a female patient, who had a right tka, reported experiencing intermittent knee pain, and now is in constant pain.She was seen by her pcp.She noted that she believed it was a recalled poly implant.She was seen by a surgeon, and an x-ray was taken.Wear and loosening were seen.The patient indicated that there is pain, instability, and loss of mobility.The surgeon prescribed celecoxib, and she has been scheduled for a future surgery.She is currently at home waiting for the scheduled revision surgery and requires the use of a walker because she can barely walk.She stated the x-ray of her knee looks like it is leaning to the side.No further information.This is 1 of 2 reports for this event.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 1, 11MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 24492311
• Report Number: 1038671-2026-00218
• Device Sequence Number: 10638601
• Product Code: JWH
• UDI-Device Identifier: 10885862174147
• UDI-Public: 10885862174147
• 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: 2016
• 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): 03/02/2026

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: 01/25/2020
• Device Catalogue Number: 02-012-47-1011
• 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: 02/16/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2012
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female