MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0235
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Implant Pain (4561)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 1998672- 02-012-35-3511 - logic tibia ps mod insrt sz 3.5 11mm.(b)(6)- 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t.1429318 - 200-02-26 - three peg patella 26mm.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 that approximately 148 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, progressive knee pain, osteolysis, aseptic loosening of femur and tibial tray, polyethylene wear of insert, surface damage, delamination and pitting on the patella, which was fractured and loose.Initial surgery and revision surgery operative notes were provided.No further issues or complications were reported.No additional information is available.Concomitant devices: (b)(6)- 02-010-01-0235 - logic femoral ps cem left sz 3.5.(b)(6)- 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t.1429318 - 200-02-26 - three peg patella 26mm.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, patellar loosening, fracture, femoral loosening, and tibial loosening, or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.H6: corrected investigation clinical codes.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 3.5
• 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: 20879152
• Report Number: 1038671-2024-04696
• Device Sequence Number: 12716234
• Product Code: JWH
• UDI-Device Identifier: 10885862001153
• UDI-Public: 10885862001153
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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,Followup
• Report Date (Section B): 05/22/2025

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: 02/22/2017
• Device Catalogue Number: 02-010-01-0235
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 05/22/2025
• Date Device Manufactured: 02/27/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male