FDA Adverse Event Injury Summary report: N

LOGIC KNEE COMPONENTS

MDR report key: 23631989 · Received November 24, 2025

Report

Report Number: 1038671-2025-03426
Event Type: Injury
Date Received: November 24, 2025
Date of Event: October 20, 2025
Report Date: November 24, 2025
Manufacturer: EXACTECH, INC.
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

D10: 02-010-04-0315 - LOGIC CR FEMORAL POR, RIGHT, SZ 1.5: (B)(6). 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T: (B)(6). 02-012-48-1509 - LOGIC TIBIAL INSERT SLOPE +, SZ 1.5, 9 MM: (B)(6). 200-02-35 - THREE PEG PATELLA 35MM: (B)(6). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

Description of Event or Problem · 0

AS REPORTED, APPROXIMATELY 9 YEARS AND 13 DAYS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO OSTEOLYSIS. ALL IMPLANTS WERE REMOVED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2390090	LOGIC KNEE COMPONENTS	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	EXACTECH, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Hospitalization\| R	SEE H11.