MAUDE Adverse Event Report: EXACTECH, INC. LOGIC PSC TIB INS SZ 3 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC PSC TIB INS SZ 3 17MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 67 yo male patient, initial right knee implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2024, approximately 5 years 9 months post the initial procedure.The patient returned to the surgeon with a recalled poly insert and was scheduled for a revision of their right knee.They underwent a full revision and were revised to a competitor¿s devices.There was a 30-45 minute surgical delay with no adverse event to the patient as a result.There were no device breakages during the procedure.The patient was last known to be in stable condition following the event.X-rays were provided.The explanted devices are not available for analysis.They are sent to the lab and legal at the hospital.Device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) - 2-010-06-0330 - tru cc femoral size 3 right.(b)(6) - 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.(b)(6) - 02-012-50-3011 - tru tib aug 1/2 size 3, 5mm.(b)(6) - 2-012-50-3011 - tru tib aug 1/2 size 3, 5mm.(b)(6) - 02-012-60-1612 - tru stem ext 16mm x 120mm.(b)(6) - 02-012-60-1880 - tru stem ext 18mm x 80mm.(b)(6) - 200-02-38 - three peg patella 38mm.(b)(6) - 204-70-00 - tibial stem ext.Screw.(b)(6) - 400-30-21 - tapered reamer.(b)(6) - 521-78-31 - threaded pin size 2.6 collarless 2pk.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: b, c, d.The reason for the revision reported was likely the result of prosthesis wear or due to the inclusion of the polyethylene in the packaging recall.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC PSC TIB INS SZ 3 17MM
• 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: matt collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19160906
• Report Number: 1038671-2024-00939
• Device Sequence Number: 7349676
• Product Code: JWH
• UDI-Device Identifier: 10885862248107
• UDI-Public: 10885862248107
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K132161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/08/2025

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: 12/19/2021
• Device Model Number: LOGIC PSC TIB INS SZ 3 17MM
• Device Catalogue Number: 02-012-44-3017
• 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: 03/31/2024
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2014
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 109 KG