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 Code	Pain (1994)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 12.5 years post the initial right total knee arthroplasty, the patient complained of pain.The patient underwent a revision due to a loose femur and recalled poly.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear, which was confirmed by the images provided.The wear coincided with potential joint instability regarding the femoral component per the attached radiographs, but the sequence of events as related to the reported wear cannot be confirmed.Additionally, these devices appear to have been implanted for over ten years prior to the reported event, so it is unlikely that there are manufacturing related contributions to the event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.D10: logic tibia fin tray cem sz 2f/2t (cat# 02-012-39-2020 / serial# (b)(6).Three peg patella 35mm (cat# 200-02-35 / serial# (b)(6).

• 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 ; 3523771140
• MDR Report Key: 21902762
• Report Number: 1038671-2025-01890
• Device Sequence Number: 8713050
• 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: 2011
• Device Explanted Year: 2024
• 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): 04/24/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2019
• 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: 02/13/2024
• Initial Report FDA Received Date: 04/24/2025
• 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
• Patient Age: 61 YR
• Patient Sex: Male