FDA Adverse Event Injury Summary report: N

LOGIC KNEE COMPONENTS

MDR report key: 23096912 · Received September 19, 2025

Report

Report Number: 1038671-2025-02950
Event Type: Injury
Date Received: September 19, 2025
Report Date: September 19, 2025
Manufacturer: EXACTECH, INC.
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

D10: 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5: (B)(6) 02-012-35-3511 - LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM: (B)(6) 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T: (B)(6). 200-02-35 - THREE PEG PATELLA 35MM: (B)(6). (B)(6) - GPS IMPLANT KIT V2: (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

IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED THAT THEY UNDERWENT AN X-RAY APPROXIMATELY 7 YEARS AND 1 MONTH AFTER INITIAL IMPLANTATION WHERE IT WAS NOTED THAT A SECOND SURGERY IS NEEDED. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1723222	LOGIC KNEE COMPONENTS	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	EXACTECH, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Other	SEE H11