MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 1; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0210
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2023-02172 d10: (b)(6) 02-012-44-1009 - logic tibia implant psc insert, sz 1, 9mm.(b)(6) 02-012-41-1010 - logic tibia trap tray cem sz 1f/1t.(b)(6) 200-02-29 - three peg patella 29mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-02172.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 50 months after a left total knee replacement procedure, the patient underwent a revision procedure to address loosening, pain, and osteolysis.Post operative diagnosis noted osteolysis and loosening of the femoral component.Surgeon performed a revision of the femoral and tibial components.No further issues or complications were reported.The patient left the operating room in stable condition.No additional information is available.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-02172.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: g4, h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral loosening.Or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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.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 1
• 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 ; 3523771140
• MDR Report Key: 21093227
• Report Number: 1038671-2025-00120
• Device Sequence Number: 8657074
• Product Code: JWH
• UDI-Device Identifier: 10885862001115
• UDI-Public: 10885862001115
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: 11/14/2021
• Device Catalogue Number: 02-010-01-0210
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female