FDA Adverse Event Injury Summary report: N

LOGIC KNEE COMPONENTS

MDR report key: 24779701 · Received April 3, 2026

Report

Report Number: 1038671-2026-00377
Event Type: Injury
Date Received: April 3, 2026
Date of Event: October 4, 2023
Report Date: April 3, 2026
Manufacturer: EXACTECH, INC.
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

02-010-01-0225 - LOGIC FEMORAL PS CEM LEFT SZ 2.5: (B)(6). 02-012-35-2511 - LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM: (B)(6). 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T: (B)(6). 200-02-29 - THREE PEG PATELLA 29MM: (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 BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 2 MONTHS AND 29 DAYS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED WITH SUPERFICIAL WOUND DEHISCENCE. 1 WEEK AND 2 DAYS LATER, THE PATIENT UNDERWENT DEBRIDEMENT AND SKIN CLOSURE WITHOUT INCIDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
837758	LOGIC KNEE COMPONENTS	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	EXACTECH, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR	Male	Required Intervention\| H