MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0350
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-012-41-5050 - logic tibia traptray cem sz 5f/5t, (b)(6), 200-02-35 - three peg patella 35mm.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
As reported, the patient presented to the surgeon¿s office with a failed right total knee replacement refractory to conservative management.It was reported that the patient suffered from pain, swelling, and difficulty walking due to poly wear.Imaging was consistent with a failed right knee arthroplasty.The patient was indicated for surgery.Approximately 9 years post the initial right total knee replacement, the patient was revised.A thorough synovectomy was performed.The patella was dislocated and the knee was flexed.The femoral implant was removed with minimal bone loss.Attention was then turned to the tibia.The tibia was removed with minimal bone loss.All cement was removed from the tibia.The femoral and tibial canals were reamed.Prior to placing the final components, a femoral head allograft was opened and cut to fill the void of bone due to osteolysis on both the medial and lateral condyles of the femur.Cement restrictors were placed in the tibial and femoral canals.A tibial cone was impacted into the tibia and fit well.Canals were irrigated, suctioned, and dried.All implants were cemented into place using pressurized cement technique in the tibial and femoral canals.A polyethylene liner trial was inserted and the knee was brought out into full extension compressing all cement.Excess cement was removed.The cement was allowed to harden.The trial was removed and a constrained polyethylene was inserted.The locking mechanism was tested and was intact.The knee was taken through range of motion.The knee was stable through an arc of motion.The knee easily came out into full extension and flex to 130 degrees.Patellar tracking was excellent.At this point the patient was closed and transferred to the recovery room in stable condition.Additional information received from the facility states that the patient was revised due to periprosthetic osteolysis and femoral debonding/loosening of the internal prosthetic right knee joint.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were added/corrected: b1, d4, g1, h4, h6: clinical code, type of investigation, investigation findings.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Based on the reported information, it appears that the pain, swelling, difficulty walking, osteolysis and synovitis may be related to the reported loosening and wear.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and 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 RIGHT SZ 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 ; 3523771140
• MDR Report Key: 23521708
• Report Number: 1038671-2025-03315
• Device Sequence Number: 9770016
• Product Code: JWH
• UDI-Device Identifier: 10885862001269
• UDI-Public: 10885862001269
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: 12/09/2017
• Device Catalogue Number: 02-010-01-0350
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2012
• 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: 66 YR
• Patient Sex: Male