FDA Adverse Event Injury Summary report: N

USTAR II KNEE SYSTEM

MDR report key: 24675622 · Received March 24, 2026

Report

Report Number
3009760038-2026-00001
Event Type
Injury
Date Received
March 24, 2026
Date of Event
February 24, 2026
Report Date
March 24, 2026
Manufacturer
UNITED ORTHOPEDIC CORPORATION
Product Code
KRO
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
IN, US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

ON (B)(6) 2024, A MALE (B)(6) UNDERWENT A TOTAL KNEE ARTHROPLASTY USING THE USTAR II KNEE SYSTEM WITH THE FOLLOWING COMPONENTS: PN: 2215-1440 TIBIAL BASEPLATE, HINGED #4, LOT 23E536C EXP. 2028-07-21. PN: 2715-5309 CEMENTED TIBIAL STEM 9MM, DIA. 70MM, LOT 21F552AK EXP. 2027-01-11. PN: 2115-1350 FEMORAL COMPONENT, HINGED #5 LEFT, LOT 23J309A EXP. 2028-09-14. PN: 2703-5054 STRAIGHT STEM PSA, 16MM DIA., 150MM, LOT 23K636AA EXP.2034-06-20. PN: 2903-1014 FEMORAL SCREW, PSA M5X14MM, LOT 24B805A EXP. 2029-03-11. PN: 2315-3245 XPE TIBIAL INSERT, M, 23MM, LOT 22E239A EXP. 2027-06-01. DJO SURGICAL COMPONENTS: PN: 355-01-002 SYMMETRIC CONE TIBIAL SM, LOT 5280A1022 EXP. 2029-09-06. PN:130-03-738 ALL-POLY E+ PATELLA DOMED TRI-PEG, 9X38MM, LOT 157N1775, EXP. 2029-11-16. THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION IN HIS LEFT KNEE. HE HAS UNDERGONE TWO RESECTIONS AND RE-IMPLANTATIONS PRIOR TO THIS OCCURRENCE. UNITED DOES NOT HAVE ACCESS TO ALL THE REVISION RECORDS. AT THIS TIME, IT IS NOT KNOWN IF (B)(6) 2024 REPRESENTS THE FIRST OR SECOND REVISION SURGERY. THE POST-OP X-RAYS FROM THE PREVIOUS SURGERY ARE AVAILABLE FOR REVIEW. THE AGENT DOES NOT HAVE ACCESS TO THE POST-OPERATION IMAGES FOR THE REVISION SURGERY ON (B)(6) 2026. THE IMPLANTS WERE EXPLANTED ON (B)(6) 2026 AND WERE NOT REPLACED WITH UNITED ORTHOPEDIC IMPLANTS. THE AGENT INDICATED THE IMPLANTS WILL NOT BE RETURNED BECAUSE THERE WAS NO IMPLANT FAILURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
256776 USTAR II KNEE SYSTEM KNEE IMPLANT KRO UNITED ORTHOPEDIC CORPORATION 2115-1350 23J309A

Patients

Seq Age Sex Outcome Treatment
1 58 YR Male Required Intervention