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 Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a 70 yo male patient, initial right knee implanted on (b)(6) 2015, underwent a revision procedure on (b)(6) 2024, approximately 9 years post the initial procedure.The patient presented with complaints of pain.The submitted report indicated the patient had a loose femur and recalled poly.The recalled poly and patella component were replaced.X-ray images were provided.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No product return for analysis anticipated.Due to recall hospital will not release.Images of the devices were provided.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 2937068 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.3840208 200-02-38 - three peg patella 38mm.2841608 02-012-35-5011 - logic tibia ps mod insrt sz 5 11mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported was likely due to the reported pain, and possibly femoral loosening.Prosthesis wear is a potential contributing factor but likely an incidental finding.Failure of the cement used to secure the implants to the respective bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Possible causes for polyethylene damage include malalignment between implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the pain, prosthesis wear and femoral loosening could not be determined as the devices were not returned for evaluation.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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18654648
• Report Number: 1038671-2024-00167
• Device Sequence Number: 8276832
• Product Code: JWH
• UDI-Device Identifier: 10885862001269
• UDI-Public: 10885862001269
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2021
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/14/2025
• Date Device Manufactured: 10/17/2013
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 108 KG