MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 02-012-45-2010 - lgc tibial fit tray cem sz 2f / 1t.(b)(6) 02-012-60-1440 - tru stem ext 14mm x 40mm.(b)(6) 204-70-00 - tibial stem ext.Screw.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 02-010-01-0320 logic femoral ps cem right sz 2.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event multiple mdr reports were filed for this event, please see associated report: 1038671-2025-02044.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.
Event or Problem Description
It was reported approximately 175 months post a right total knee arthroplasty, the patient presented with pain and approximately a week later underwent scheduled a second right knee revision procedure of the femoral component insert and patella components.It was noted the insert and patella were replaced due to recalls and the femoral component was significantly loose.Pictures of the explants were provided.There were no surgical delays or medical interventions reported.The patient was last known to be in stable condition following the event.No additional information is available.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear, femoral loosening, and inclusion of the polyethylene in the packaging recall.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.The reported femoral loosening may have been caused by the malalignment between the femoral component and the tibial insert, however, femoral loosening could not be confirmed from the provided information.H6: corrected health effect and investigation clinical codes.H10 related report numbers: 1038671-2025-02044, 1038671-2025-02170, 1038671-2025-02171 and 1038671-2025-02172.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22009551
• Report Number: 1038671-2025-02045
• Device Sequence Number: 20172267
• Product Code: JWH
• UDI-Device Identifier: 10885862001733
• UDI-Public: 10885862001733
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• 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): 06/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2022
• Device Catalogue Number: 02-012-35-2011
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/25/2025
• Date Device Manufactured: 03/12/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female