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

Catalog Number	02-010-03-0235
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2015, and then experienced revision surgical procedure on (b)(6) 2023 approximately 8 years and 1 month after initial implant.Postoperative diagnosis ; femoral loosening and extensive poly wear osteolysis.No images were provided.There is no other information available.
Additional Manufacturer Narrative
H10.D10.Concomitants: (b)(6) 02-010-03-0335 - logic cr femoral cem, right, sz 3.5, (b)(6) 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t, (b)(6) 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t, (b)(6) 200-02-38 - three peg patella 38mm, (b)(6) 200-02-38 - three peg patella 38mm, (b)(6) 201-46-10 - holding pin headless 3" (4 pk).These devices are used for treatments, not diagnosis.There is no other information available.
Additional Manufacturer Narrative
H11.Updated/additional information ¿ g1.G2.G4.H6.The revision reported was likely the result of polyethylene wear, femoral loosening and osteolysis as stated in the operative notes.The aseptic (non-infected) femoral loosening may have been the result of an insufficient bond between the femoral component and the bone, and/or patient-related conditions.The prosthesis wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the reason for the reported femoral loosening, osteolysis, and prosthesis wear could not be confirmed as the devices were not returned for evaluation, and images/radiographs were unable to be obtained.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: LOGIC CR FEMORAL 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19094607
• Report Number: 1038671-2024-00812
• Device Sequence Number: 15305622
• Product Code: JWH
• UDI-Device Identifier: 10885862158024
• UDI-Public: 10885862158024
• Combination Product (Y/N): N
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2025

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: 11/11/2023
• Device Catalogue Number: 02-010-03-0235
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 05/15/2024; 02/07/2025
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/05/2024; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Unknown