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

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Osteolysis (2377); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitant devices: (b)(6), 02-012-35-5011 - logic tibia ps mod insrt sz 5 11mm, (b)(6), 200-02-41 - three peg patella 41mm, (b)(6), 02-010-01-0350 - logic femoral ps cem right sz 5, (b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.
Event or Problem Description
It was reported that approximately 91 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, possible nickel allergy, extensive damage to the posterior aspect of the polyethylene as well as to the post, soft tissue changes consistent with extensive poly wear, fragments of poly found in soft tissue, poly wear of the patella button, and a loose femoral component.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
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.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.H6: corrected health effect clinical codes.

• 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
• MDR Report Key: 21552483
• Report Number: 1038671-2025-01502
• Device Sequence Number: 8175674
• Product Code: JWH
• UDI-Device Identifier: 10885862001269
• UDI-Public: 10885862001269
• 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: 2024
• 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): 06/16/2025

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: 02/13/2021
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 5
• Device Catalogue Number: 02-010-01-0350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 02/02/2016
• 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: 64 YR
• Patient Sex: Male