AS VEGA System® PS NX016ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963809980), received between Aug 27, 2025 and Jul 27, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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 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.

• InjuryJul 27, 2026Patient-Device Incompatibility

  An outside law firm reported that a patient experienced loosening of the left knee prosthesis. According to the available medical records, the patient underwent a left total knee arthroplasty on (B)(6) 2022, for left knee osteoarthritis. The procedure utilized an Aesculap Vega system. The operative report documented that the procedure was completed without reported intraoperative complications. Intraoperative trialing demonstrated full extension and flexion with appropriate patellar tracking. The implants were placed using third-generation cement technique, and the patient was taken to the post-anesthesia care unit in stable condition. On (B)(6) 2026, the patient was evaluated for left knee pain. The assessment included mechanical loosening of the internal left knee prosthetic joint. A triple-phase bone scan was reported as normal with no prosthetic loosening, fracture, or osteomyelitis; however, the treating physician documented disagreement with the radiology interpretation, noting increased uptake along the patellar component and underneath the femoral component. The patient was reportedly tender in this area, and the physician documented that the findings were consistent with l

  Patient problems: Insufficient Information

  MAUDE report 50039948 ↗
• InjuryAug 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE LEFT KNEE FOR LOOSENING AND FAILURE OF PRIOR COMPONENTS. THE FEMORAL COMPONENT WAS EXPLANTED MANUALLY; THE TIBIAL COMPONENT WAS REMOVED WITH SUBLUXATION AND PERIOSTEAL ELEVATOR. SEVERE DEBONDING WAS NOTED AT BOTH FEMORAL AND TIBIAL INTERFACES, CONSISTENT WITH ASEPTIC LOOSENING. THE TIBIA AND FEMUR WERE SEQUENTIALLY PREPARED WITH BROACHES, REAMERS, AND CUTTING GUIDES. TRIAL IMPLANTS WERE PLACED AND DEMONSTRATED STABLE FIXATION WITH EXCELLENT RANGE OF MOTION AND VARUS/VALGUS STABILITY. FINAL TIBIAL AND FEMORAL IMPLANTS WERE IMPLANTED USING THIRD-GENERATION CEMENTING TECHNIQUE (VACUUM MIXED, PULSE LAVAGE PREPARATION, DIGITAL PRESSURIZATION). A POLYETHYLENE INSERT WAS PLACED, CONFIRMED TO BE WELL-SEATED, AND SECURED WITH A LOCKING SCREW. THE PATIENT TOLERATED THE PROCEDURE, WAS AWAKENED FROM ANESTHESIA, AND TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 22903554 ↗