FDA Adverse Event Injury Summary report: N

THREE PEG PATELLA 32MM

MDR report key: 23509955 · Received November 10, 2025

Report

Report Number: 1038671-2025-03301
Event Type: Injury
Date Received: November 10, 2025
Date of Event: October 9, 2025
Report Date: November 10, 2025
Manufacturer: EXACTECH, INC.
Product Code: JWH
UDI-DI: 00885862039590
PMA / PMN Number: K932690
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

D10: 02-012-47-5011 LOGIC CR TIB INSERT STD, SZ 5, 11MM: SN# (B)(6), 02-010-03-0350 - LOGIC CR FEMORAL CEM, RIGHT, SZ 5: SN# (B)(6), 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T: SN# (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED POLYETHYLENE WEAR, SYNOVITIS, INFLAMMATION, PAIN, LOSS OF RANGE OF MOTION AND DISSATISFACTION WITH THEIR LEFT TOTAL KNEE. AS A RESULT, APPROXIMATELY NINE YEARS AND FOUR MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 2 FOR THIS EVENT/PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2616085	THREE PEG PATELLA 32MM	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	EXACTECH, INC.			00885862039590

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR	Male	Hospitalization	SEE H11.