VEGA System® PS+ NX221Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046963811198), received between Dec 18, 2020 and Aug 17, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Patient-Device Incompatibility

  An outside law firm reported that a patient experienced loosening of the right knee prosthesis. The patient underwent right total knee arthroplasty on (b)(6), 2018 for right knee degenerative joint disease. The operative report documents implantation of total knee arthroplasty components. The procedure was completed without reported intraoperative complications, and the patient was transferred to the PACU in stable condition. Postoperative follow-up on (b)(6), 2018 documented that the right knee was straight and anatomically aligned and that the patient had no complaints or problems. On (b)(6), 2018, the patient reported feeling something "pop" anteriorly around the knee and had anterior tenderness. Radiographs were reported as completely normal. The patient received an intramuscular Depo-Medrol injection for pain and swelling. At follow-up on (b)(6), 2018, the patient was reported to be significantly improved, although some lateral collateral ligament symptoms remained. On (b)(6), 2018, the patient was reported to be doing fairly well, with keloid formation/scarring and continued patellofemoral pain. On (b)(6), 2026, approximately eight years after the index arthroplasty, the pati

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 50275307 ↗
• InjuryJun 9, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES INVOLVING A RIGHT KNEE PROSTHESIS. ACCORDING TO OPERATIVE RECORDS, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022, FOR AVASCULAR NECROSIS (AVN) OF THE LATERAL TIBIAL PLATEAU. THE PROCEDURE UTILIZED AESCULAP VEGA COMPONENTS WHICH WERE CEMENTED USING PALACOS CEMENT. THE OPERATIVE REPORT INDICATED THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INTRAOPERATIVE COMPLICATIONS, AND THE KNEE DEMONSTRATED FULL EXTENSION AND FLEXION WITH CENTRAL PATELLAR TRACKING AT THE CONCLUSION OF SURGERY. AT A FOLLOW-UP VISIT ON (B)(6) 2023, THE PATIENT REPORTED CONTINUED PAIN AND DISCOMFORT, AS WELL AS WEAKNESS INVOLVING THE QUADRICEPS. RADIOGRAPHS OF THE KNEE WERE OBTAINED, AND QUADRICEPS WEAKNESS WAS NOTED ON EXAMINATION. AT A SUBSEQUENT FOLLOW-UP ON OCTOBER 22, 2024, THE PATIENT REPORTED PAIN AND DISCOMFORT INVOLVING THE RIGHT KNEE. PHYSICAL EXAMINATION DOCUMENTED INSTABILITY OF THE KNEE JOINT, AND THE PATIENT REPORTED FALLS AND FUNCTIONAL DIFFICULTIES. REVISION SURGERY WAS DISCUSSED. DURING A FOLLOW-UP VISIT ON (B)(6) 2025, THE PATIENT CONTINUED TO REPORT INSTABILITY AND RECURRENT FALLS. EXAMINATION DOCUMENTED

  Patient problems: Failure of Implant

  MAUDE report 25448579 ↗
• InjuryNov 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT THE KNEE IMPLANT WAS DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT. REPORTEDLY THE PATIENT UNDERWENT A REVISION PROCEEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 23534997 ↗
• InjuryDec 18, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  NO UPDATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037532 ↗