"UNITED" USTAR II Knee SystemRecalls & reported problems across all models
United Orthopedic Corp. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one "UNITED" USTAR II Knee System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 3
We found 22 models of "UNITED" USTAR II Knee System by United Orthopedic Corp. in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2021 and Aug 13, 2026 — classified as 14 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (11 reports).
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
"UNITED" USTAR II Knee System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 3, 2024Open, Classified
Their is a potential that the implant curved stem may be oriented incorrectly.
Z-1217-2024 · Root cause: Nonconforming Material/Component · names 12 of these models · Recall details · FDA record ↗
- Jan 3, 2024Open, Classified
Their is a potential that the implant curved stem may be oriented incorrectly.
Z-1216-2024 · Root cause: Nonconforming Material/Component · names 12 of these models · Recall details · FDA record ↗
- Aug 27, 2021Terminated
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
Z-0110-2022 · Root cause: Device Design · Recall details · FDA record ↗
Most reported "UNITED" USTAR II Knee System problems
Device problems
- Break11
- Deformation Due to Compressive Stress5
- Fracture5
- Detachment of Device or Device Component3
- Material Separation2
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Failure to Align1
Patient problems
- Hyperextension6
- Hip Fracture3
- Joint Dislocation3
- Joint Laxity3
- Limb Pain3
- Administration Site Reaction1
- Bone Shedding Debris1
- Subluxation1
"UNITED" USTAR II Knee System models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- "UNITED" USTAR II Knee System 2515-1117Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-1217Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3217Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-1209Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-1213Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-1415Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3209Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-1111Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-1115Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3111Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2915-1025Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall3 reports
- "UNITED" USTAR II Knee System 2115-3410Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer5 reports
- "UNITED" USTAR II Knee System 2115-3310Prosthesis, Hip, Hemi-, Femoral, Metal2 reports
- "UNITED" USTAR II Knee System 2315-3211Prosthesis, Hip, Hemi-, Femoral, Metal1 report
- "UNITED" USTAR II Knee System 2315-3213Prosthesis, Hip, Hemi-, Femoral, Metal1 report
- "UNITED" USTAR II Knee System 2315-3216Prosthesis, Hip, Hemi-, Femoral, Metal1 report
- "UNITED" USTAR II Knee System 2315-3243Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- "UNITED" USTAR II Knee System 2315-3244Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- "UNITED" USTAR II Knee System 2115-3400Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- "UNITED" USTAR II Knee System 2115-1330Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
Recent "UNITED" USTAR II Knee System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Break
A complaint case regarding the distal femoral component was received by the French branch on (b)(6) 2026. A 51-year-old male patient underwent TKA surgery using the USTAR II Knee System on (b)(6) 2024. The patient experienced a fall several months earlier and subsequently developed pain. At the follow-up visit on (b)(6) 2026, the X-ray showed intra-articular bone fragments and fracture of the prosthesis hinge component. A revision surgery was performed on (b)(6) 2026.
Patient problems: Bone Shedding Debris; Limb Pain
MAUDE report 50232496 ↗InjuryApr 30, 2026Break; Structural Problem; Deformation Due to Compressive Stress
A PATIENT, ONE YEAR AFTER UNDERGOING KNEE JOINT REPLACEMENT SURGERY, FELT SOMETHING BREAK INSIDE THE BODY WHILE GETTING OUT OF A CAR. AN X-RAY EXAMINATION SHOWED A FRACTURE AT THE YOKE OF THE TIBIAL INSERT. A REVISION SURGERY WAS SUBSEQUENTLY PERFORMED.
Patient problems: Joint Dislocation
MAUDE report 25038877 ↗InjuryApr 29, 2026Unintended System Motion; Unstable; Naturally Worn
A PATIENT UNDERWENT TKA SURGERY IN (B)(6) 2024. ONE YEAR POSTOPERATIVELY, THE PATIENT BEGAN EXPERIENCING NOISE DURING KNEE MOVEMENT AND JOINT INSTABILITY; A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025.
Patient problems: Joint Laxity
MAUDE report 25038514 ↗InjuryApr 29, 2026Break; Fracture; Deformation Due to Compressive Stress
A PATIENT UNDERWENT TKA SURGERY ON (B)(6) 2022. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO THE TIBIAL INSERT RUPTURE ON THE YOKE PART WAS OBSERVED BY X-RAYS.
Patient problems: Hyperextension
MAUDE report 25038513 ↗InjuryApr 29, 2026Fracture; Failure to Align; Mechanics Altered
THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2024 THAT A PATIENT HAD UNDERGONE KNEE ARTHROPLASTY TWO YEARS EARLIER. THE PATIENT LATER RETURNED FOR FOLLOW-UP DUE TO PAIN, AND X-RAY IMAGES SHOWED FRACTURES OF THE SCREW AND THE METAL PORTION OF THE INSERT. A REVISION SURGERY WAS SUBSEQUENTLY PERFORMED.
Patient problems: Hyperextension
MAUDE report 25038512 ↗InjuryApr 29, 2026Loss of Osseointegration; Deformation Due to Compressive Stress; Device Dislodged or Dislocated
A PATIENT UNDERWENT A TKA SURGERY ON (B)(6) 2024. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2025 DUE TO KNEE JOINT INSTABILITY. PRE-OPERATIVE X-RAYS SHOWED YOKE BRAKEAGE, AND THE FEMORAL COMPONENT LOOSENING WAS OBSERVED DURING THE SURGERY.
Patient problems: Administration Site Reaction
MAUDE report 25038511 ↗InjuryApr 29, 2026Break; Fracture; Deformation Due to Compressive Stress
A PATIENT UNDERWENT TKA SURGERY ON (B)(6) 2024. THE PATIENT BEGAN EXPERIENCING NOISE DURING KNEE MOVEMENT AFTER SURGERY; A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THE HINGE CONSTRUCTURE FAILURE OF IMPLANTS WAS OBSERVED.
Patient problems: Hyperextension
MAUDE report 25038509 ↗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 ↗InjuryApr 29, 2026Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Misassembled During Installation
A PATIENT UNDERWENT AN IMPLANTATION WITH USTAR II KNEE SYSTEM AND EXPERIENCED A DISSOCIATION OF THE USTAR II DISTAL FEMORAL COMPONENT ON (B)(6) 2020. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020.
Patient problems: Joint Dislocation; Subluxation
MAUDE report 25038504 ↗InjuryApr 29, 2026Break; Fracture
A PATIENT UNDERWENT THE TOTAL KNEE JOINT REPLACEMENT ON (B)(6) 2022. TWO YEARS POSTOPERATIVELY, THE PATIENT REPORTED A SENSATION OF DISLOCATION WITHOUT HISTORY OF FALLS, COLLISIONS, OR STRENUOUS ACTIVITY. DURING A REVISION SURGERY PERFORMED ON (B)(6) 2024, THE RETRIEVED IMPLANT REVEALED THAT THE TIBIAL INSERT COMPONENT HAD FRACTURED.
Patient problems: Hyperextension
MAUDE report 25038503 ↗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 ↗InjuryDec 12, 2024Break; Material Separation; Detachment of Device or Device Component; Break; Material Separation; Detachment of Device or Device Component
ON (B)(6) 2024, A FEMALE PATIENT (M.A.E., 120 LBS) UNDERWENT A SURGERY USING THE USTAR II KNEE SYSTEM. THE PROCEDURE INVOLVED IMPLANTATION OF THE FOLLOWING COMPONENTS: 1. USTAR II KNEE SYSTEM DISTAL FEMORAL COMPONENT, RHS, S, RIGHT (PN: 2115-3410, LOT: 23J480A) 2. USTAR II KNEE SYSTEM XPE TIBIAL INSERT, S, 12MM (PN: 2315-3211, LOT: 23E194A) THE SURGERY FOLLOWED STANDARD PROTOCOLS AND WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POST-OPERATIVE RECOVERY PROCEEDED AS EXPECTED, AND THE PATIENT WAS DISCHARGED. APPROXIMATELY FOUR MONTHS POST-SURGERY, WHILE AMBULATING WITHOUT ADDITIONAL LOAD, THE PATIENT REPORTED AN AUDIBLE "POP" FOLLOWED BY KNEE INSTABILITY. CLINICAL EXAMINATION AND IMAGING STUDIES REVEALED IMPLANT FRACTURE NECESSITATING REVISION SURGERY ON (B)(6) 2024. IT IS NOTED THAT SURGEON WHO PERFORMED INITIAL SURGERY ON (B)(6) 2024 AND THE SURGERY PERFORMING ON (B)(6) 2024 (DR. (B)(6) MD) CHOSE TO USE THE SAME USTAR II KNEE SYSTEM TO PERFORM REVISION SURGERY. THE REVISION PROCEDURE, PERFORMED ON (B)(6) 2024, INVOLVED: 1 EXPLANTATION OF THE ORIGINAL COMPONENTS (PN: 2115-3410, LOT: 23J480A AND PN: 2315-3211, LOT: 23E194A). 2 IMPLANTATION OF NEW USTAR II KNEE SYSTEM COMPONENTS
Patient problems: Joint Laxity; Limb Pain
MAUDE report 20919918 ↗InjuryDec 4, 2024Break; Material Separation; Detachment of Device or Device Component; Break; Material Separation; Detachment of Device or Device Component
ON (B)(6) 2024, A FEMALE PATIENT (M.A.E., 120 LBS) UNDERWENT A SURGERY USING THE USTAR II KNEE SYSTEM. THE PROCEDURE INVOLVED IMPLANTATION OF THE FOLLOWING COMPONENTS: 1. USTAR II KNEE SYSTEM DISTAL FEMORAL COMPONENT, RHS, S, RIGHT (PN: 2115-3410, LOT: 23J480A). 2. USTAR II XPE TIBIAL INSERT, S, 12MM (PN: 2315-3211, LOT: 23E194A). THE SURGERY FOLLOWED STANDARD PROTOCOLS AND WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POST-OPERATIVE RECOVERY PROCEEDED AS EXPECTED, AND THE PATIENT WAS DISCHARGED. APPROXIMATELY FOUR MONTHS POST-SURGERY, WHILE AMBULATING WITHOUT ADDITIONAL LOAD, THE PATIENT REPORTED AN AUDIBLE "POP" FOLLOWED BY KNEE INSTABILITY. CLINICAL EXAMINATION AND IMAGING STUDIES REVEALED IMPLANT FRACTURE NECESSITATING REVISION SURGERY ON (B)(6) 2024. IT IS NOTED THAT SURGEON WHO PERFORMED INITIAL SURGERY ON (B)(6)2024 AND THE SURGERY PERFORMING ON (B)(6)2024 (DR.(B)(6) MD) CHOSE TO USE THE SAME USTAR II KNEE SYSTEM TO PERFORM REVISION SURGERY. THE REVISION PROCEDURE, PERFORMED ON (B)(6) 2024, INVOLVED: 1 EXPLANTATION OF THE ORIGINAL COMPONENTS (PN: 2115-3410, LOT: 23J480A AND PN: 2315-3211, LOT: 23E194A). 2 IMPLANTATION OF NEW USTAR II KNEE SYSTEM COMPONENTS: A) USTAR II
Patient problems: Joint Laxity; Limb Pain
MAUDE report 20846835 ↗InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE PATIENT REPORTED THAT THEY GOT OUT OF A CHAIR AND EXPERIENCED PAIN. THEY INDICATED NO FALL OR TRAUMA. PREVIOUS USTAR II PATIENT PRESENTED WITH PAIN AND INSTABILITY. X-RAY IMAGING REVEALED DISLOCATION OF THE FEMORAL COMPONENT AND TIBIAL INSERT YOKE AND A REVISION WAS SCHEDULED. DURING SURGERY, SURGEON NOTED THE INSERT SCREW CONNECTING THE FEMORAL COMPONENT INSERT AND YOKE HAD BENT. ORIGINAL SURGERY WAS ON (B)(6) 2023 AND REVISION WAS CONDUCTED ON (B)(6) 2024. REVISION SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: Joint Dislocation
MAUDE report 18834187 ↗MalfunctionJun 29, 2023Break; Break
UPON X-RAY EVALUATION DR. (B)(6) DETERMINED THE 25-MM SEGMENT ON THE FEMORAL SIDE HAD BROKEN. A REVISION SURGERY WAS SCHEDULED, AND THE 25-MM SEGMENT WAS SUCCESSFULLY EXTRACTED AND REPLACED WITH A UNITED 30-MM SEGMENT ON (B)(6) 23.
Patient problems: Hip Fracture
MAUDE report 17222914 ↗
Other United Orthopedic Corp. products
All United Orthopedic Corp. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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