MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0240
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Report # 2 of 2 for this event.It was reported a patient underwent a left total knee arthroplasty.Subsequently, six (6) years later, a bone scan revealed polymeric-induced synovitis and circumferential bone resorption over the patella.Due to worsening pain and instability, five (5) months post the bone scan, the patient underwent left knee revision.Revision notes from the surgeon noted the patient presented with failure of the total knee replacement.There was exuberant synovitis throughout the entirety of the knee joint.Synovitis was consistent with significant polyethylene wear disease and loosening of the femoral component.A large cystic probably induced cavity was found in the lateral femoral condyle.The tibial tray had no evidence of loosening.The patient was revised to a different manufacture's knee system.The patient was transferred to the recovery room in stable condition no additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) optetrak 3-peg patella 38mm (b)(6) optetrak logic tibial tray sz 4f/4t - 02-012-41-4040 (b)(6), category #: 02-012-44-4011 - logic tibia implant psc insert, sz 4, 11mm.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2023-00295.The revision reported was likely the result of prosthesis wear and an insufficient bond between the components and the bones, which resulted in aseptic (non-infected) loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The device history record for this femoral component was reviewed, and all components were accepted with conformance to the device requirements.A review of complaint history determined that no further action is required as no trends were identified.The extent and root cause of this polyethylene wear and loosening could not be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 4
• 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: katy priest ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 25234569
• Report Number: 1038671-2026-00615
• Device Sequence Number: 10184081
• Product Code: JWH
• UDI-Device Identifier: 10885862001160
• UDI-Public: 10885862001160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 04/06/2016
• Device Catalogue Number: 02-010-01-0240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2023
• Initial Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 04/06/2016
• 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; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male