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 Code	Pain (1994)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 3940520.201-78-89 - 3" drill bit, mod.Hex 2 pack.4124121.02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t.4143124.200-02-32 - three peg patella 32mm.4149968.201-78-82 - collar fixation pin 2pk 40mm, quick release.4136649.02-010-01-0235 - logic femoral ps cem left sz 3.5.The revision reported was likely the result of prosthesis wear that may have been secondary to gross instability of the knee and other patient-related issues.A contributing factor to the extent of wear on the tibial insert may have been the result of being packaged in a non-conforming bag for five years.Prosthesis wear may have contributed to particle-induced osteolysis.The reported femoral loosening due to loss of mechanical fixation at the cement-implant interface may be the result of the revision procedure as the operative report states that it appeared to be well-fixed at the time of initial testing.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported, approximately 7 years post op the initial left tka, this 59 y/o patient was revised due to pain and wear.Patient had a recalled implant.The medial aspect of the joint space seemed slightly thinner than the lateral aspect indicating wear.The femur debonded from the cement mantle.The poly showed signs of degradation and wear.Patient was last known to be in stable condition following the event.No other patient/medical information provided.Devices are not returning; the hospital does not allow for the return of explants.The patient was revised to exactech devices.No breakage of a device or surgical delay/prolongation.There were no broken instruments.This was an implant issue.

• 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: 22467533
• Report Number: 1038671-2025-02465
• Device Sequence Number: 7940904
• Product Code: JWH
• UDI-Device Identifier: 10885862001153
• UDI-Public: 10885862001153
• 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: 2015
• Device Explanted Year: 2022
• 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): 07/10/2025

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: 10/05/2020
• 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: 12/14/2022
• Initial Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 10/08/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 59 YR
• Patient Sex: Female