"UNITED" USTAR II Knee System 2115-3310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04719872179436), received between Nov 22, 2025 and Apr 29, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K190100); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Break; Fracture; Deformation Due to Compressive Stress

  A PATIENT UNDERWENT KNEE JOINT REPLACEMENT SURGERY ON (B)(6) 2022. TWO YEARS POSTOPERATIVELY, THE PATIENT SOUGHT MEDICAL CONSULTATION DUE TO PAIN, AND A REVISION SURGERY WAS SUBSEQUENTLY PERFORMED ON (B)(6), 2024. THE FEMORAL COMPONENT WAS FOUND TO BE FRACTURED AND SEVERELY WORN.

  Patient problems: Hyperextension

  MAUDE report 25038508 ↗
• InjuryNov 22, 2025Unintended Movement; Unintended Movement

  ON (B)(6) 2024, A FEMALE PATIENT ((B)(6)) UNDERWENT A TOTAL KNEE ARTHROPLASTY UTILIZING THE USTAR II KNEE SYSTEM. THE PRIMARY PROCEDURE INVOLVED IMPLANTATION OF THE FOLLOWING COMPONENTS: · USTAR II KNEE SYSTEM DISTAL FEMORAL COMPONENT, RHS, SIZE S, LEFT (PN: 2115-3310, LOT: 22C065B). · USTAR II KNEE SYSTEM TIBIAL BASEPLATE, HINGED (PN: 2215-1430, LOT: 23F304D) · USTAR II KNEE SYSTEM SEGMENT PART, RHS 120MM LENGTH (PN: 2915-1120, LOT: 17K11713) · USTAR II KNEE SYSTEM TIBIAL STEM 14 X 120MM (PN: 2715-7514, LOT: 22G669GZ) · USTAR II KNEE SYSTEM CEMENTED STRAIGHT STEM, RHA NON-COATED 15 X 125MM (PN: 2715-3115, LOT: 20E327F). · USTAR II KNEE SYSTEM XPE TIBIAL INSERT (PN: 23315-3213, LOT: 23J382B). THE IMPLANTATION WAS PERFORMED ACCORDING TO THE MANUFACTURER'S SURGICAL TECHNIQUE GUIDELINES. THE SURGERY WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS, AND THE PATIENT'S INITIAL POST-OPERATIVE RECOVERY WAS NORMAL. THE PATIENT WAS SUBSEQUENTLY DISCHARGED FOLLOWING STANDARD POST-SURGICAL EVALUATION. APPROXIMATELY ONE YEAR POST-OPERATIVELY, DURING CLINICAL FOLLOW-UP, THE PATIENT PRESENTED WITH EXCESSIVE KNEE HYPEREXTENSION WHICH EXCEEDS THE MANUFACTURER'S SPECIFIED RANGE. RADIOGRAPHIC IMAGI

  Patient problems: Hyperextension

  MAUDE report 23625041 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190100. One submission often covers many models, so check the product and lot details in each record.

• Z-2884-2026 · May 20, 2026 · Open, Classified
  Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Sof
• Z-1217-2024 · Jan 3, 2024 · Open, Classified
  USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE2515111
• Z-1215-2024 · Jan 3, 2024 · Open, Classified
  USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE1
• Z-1216-2024 · Jan 3, 2024 · Open, Classified
  USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111-
• Z-0110-2022 · Aug 27, 2021 · Terminated
  United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025