VEGA System® PS+ NX210Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046963811129), received between Sep 8, 2025 and Aug 14, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Patient-Device Incompatibility

  An outside law firm reported that a patient experienced postoperative loosening and instability following a right total knee arthroplasty. According to the available medical records, the patient underwent a right total knee arthroplasty on (b)(6) 2021. The patient subsequently developed loosening of the right total knee arthroplasty with gross instability. On (b)(6) 2024, the patient underwent revision right total knee arthroplasty involving the femoral and tibial components. The preoperative and postoperative diagnoses were documented as right knee loose total knee arthroplasty with gross instability. During the revision procedure, the femoral component was visualized and reportedly came right off when grasped. The tibial prosthesis was loosened and removed easily with minimal bone loss. The patellar button was also assessed intraoperatively and was documented to be loose. The femur and tibia were prepared for revision components. Following trialing, the knee demonstrated full range of motion with excellent stability to varus and valgus stress. The revision components were cemented into place using a third-generation cement technique. The patient was awakened from surgery and take

  Patient problems: Insufficient Information

  MAUDE report 50260855 ↗
• InjuryAug 14, 2026Patient-Device Incompatibility

  An outside law firm reported that a patient experienced postoperative loosening following a left total knee arthroplasty. According to the available medical records, the patient underwent a left total knee arthroplasty on (b)(6) 2021. On (b)(6) 2024, the patient underwent revision of the left patellar component for aseptic loosening. The operative report documented that the femoral and tibial components were inspected and appeared to have no loosening. The patellar button was evaluated, and when an osteotome was placed at the medial side of the button, the button reportedly popped out. The remaining cement was removed from the patella and the patella was resurfaced to allow for improved tracking. No intraoperative complications were reported, and the patient was taken to recovery in stable condition. Subsequent records documented further concerns involving the left total knee prosthesis. At a (b)(6) 2025 postoperative evaluation, radiographs demonstrated a posterior-stabilized total knee repement with the patella resurfaced. The femoral component appeared loose, with severe periprosthetic osteolysis about the femur. The patient was assessed with mechanical loosening and periprosthe

  Patient problems: Insufficient Information

  MAUDE report 50260354 ↗
• InjuryJun 9, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING RIGHT KNEE PAIN AND INSTABILITY FOLLOWING A RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT HAD A HISTORY OF END-STAGE DEGENERATIVE ARTHRITIS OF THE RIGHT KNEE AND UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020. FOLLOWING SURGERY, THE PATIENT CONTINUED TO REPORT PAIN, SWELLING, AND INSTABILITY. A CLINIC VISIT ON (B)(6) 2021, DOCUMENTED CONTINUED KNEE SWELLING AND LATERAL PATELLAR TRACKING. SUBSEQUENT EVALUATION NOTED A WELL-HEALED INCISION, RANGE OF MOTION FROM 0 TO 110 DEGREES, AND MID-FLEXION INSTABILITY WITH VARUS/VALGUS LAXITY. RADIOGRAPHS REPORTEDLY DEMONSTRATED A WELL-ALIGNED PROSTHESIS WITHOUT EVIDENCE OF LOOSENING, FRACTURE, OR MECHANICAL FAILURE. DUE TO PERSISTENT PAIN AND INSTABILITY, THE PATIENT UNDERWENT REVISION RIGHT TOTAL KNEE ARTHROPLASTY INVOLVING POLYETHYLENE EXCHANGE ON (B)(6) 2021. INTRAOPERATIVE FINDINGS INCLUDED SIGNIFICANT MEDIAL-LATERAL INSTABILITY, CREPITATION, SYNOVIAL SWELLING, AND CLEAR JOINT FLUID WITHOUT EVIDENCE OF INFECTION. THE EXISTING POLYETHYLENE INSERT WAS REMOVED AND REPLACED WITH A SIZE 14 AESCULAP POSTERIOR-STABILIZED POLYETHYLENE INSERT. SYNOVECTOMY, DEBRIDEMENT, AND REMOVA

  Patient problems: Failure of Implant

  MAUDE report 25448581 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS FOLLOWING A RIGHT KNEE PROSTHESIS THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2021, THE PATIENT UNDERWENT A PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY FOR TRICOMPARTMENTAL DEGENERATIVE JOINT DISEASE (DJD) WITH VARUS DEFORMITY. THE PROCEDURE WAS PERFORMED USING AESCULAP VEGA COMPONENTS, WHICH WERE CEMENTED IN PLACE USING PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THAT THE COMPONENTS WERE IMPLANTED WITH APPROPRIATE ALIGNMENT AND STABILITY, WITH CENTRAL PATELLAR TRACKING AND NO EVIDENCE OF VARUS OR VALGUS INSTABILITY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO RECOVERY IN GOOD CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED JUNE 30, 2025, THE PATIENT UNDERWENT A REVISION RIGHT TOTAL KNEE ARTHROPLASTY DUE TO FAILURE OF THE PRIOR KNEE REPLACEMENT WITH LOOSENING OF COMPONENTS. INTRAOPERATIVELY, BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE NOTED TO BE LOOSE WITH FRAGMENTATION OF CEMENT AND WERE REMOVED WITHOUT SIGNIFICANT DIFFICULTY. REVISION WAS PERFORMED USING ANOTHER MANUFACTURER'S COMPONENTS

  Patient problems: Failure of Implant

  MAUDE report 24653770 ↗
• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020, THE PATIENT UNDERWENT RIGHT KNEE MANIPULATION UNDER ANESTHESIA FOR RIGHT KNEE STIFFNESS AFTER TOTAL KNEE ARTHROPLASTY (TKA). ON (B)(6) 2023, THE PATELLAR BUTTON WAS REPLACED DUE TO ASEPTIC LOOSENING. FINDINGS DURING THE REVISION ON (B)(6) 2025 INCLUDED DEBONDING OF CEMENT FROM TIBIA AND FEMUR, GROSSLY LOOSE TIBIA AND FEMUR; NON-AESCULAP IMPLANTS WERE USED INSTEAD. ANOTHER RIGHT KNEE MANIPULATION UNDER ANESTHESIA FOR RIGHT KNEE STIFFNESS WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Failure of Implant

  MAUDE report 22994369 ↗