VEGA System® PS+ NX222Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963811204), received between Feb 26, 2021 and Jun 12, 2026 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING COMPLICATIONS ASSOCIATED WITH A VEGA KNEE IMPLANT. A REVISION SURGERY HAS NOT YET BEEN SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25484829 ↗
• InjuryApr 27, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES INVOLVING THE RIGHT KNEE FOLLOWING DEGENERATIVE JOINT DISEASE AND SUBSEQUENT SURGICAL INTERVENTION. ACCORDING TO CLINICAL DOCUMENTATION, THE PATIENT PRESENTED ON (B)(6) 2021 WITH CHRONIC RIGHT KNEE PAIN DUE TO END-STAGE OSTEOARTHRITIS, HAVING FAILED CONSERVATIVE MANAGEMENT INCLUDING MULTIPLE INJECTIONS. A RIGHT TOTAL KNEE ARTHROPLASTY WAS RECOMMENDED. THE PATIENT SUBSEQUENTLY UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021. OPERATIVE RECORDS INDICATE THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS, WITH PROPER PLACEMENT OF PROSTHETIC COMPONENTS AND STABLE RANGE OF MOTION ACHIEVED INTRAOPERATIVELY. FOLLOWING SURGERY, THE PATIENT WAS SEEN ON (B)(6) 2021 AFTER A REPORTED FALL, WITH CONTINUED PAIN BUT NO IMMEDIATE EVIDENCE OF SURGICAL FAILURE. AT FOLLOW-UP ON (B)(6) 2022, THE PATIENT WAS NOTED TO BE RECOVERING FAIRLY WELL, THOUGH SHE HAD DIFFICULTY ATTENDING PHYSICAL THERAPY AND CONTINUED TO HAVE WEAKNESS. ON (B)(6) 2022, THE PATIENT REPORTED ONGOING KNEE PAIN WITH EPISODES OF INSTABILITY AND FALLS, WITH EXAMINATION NOTING LIGAMENTOUS LAXITY. ADDITIONAL TREATMENT INCLUDED A CORTICOSTEROID I

  Patient problems: Failure of Implant

  MAUDE report 24998744 ↗
• InjuryFeb 26, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH VEGA PS KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE IMPLANT WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2014, AND THE REVISION OCCURRED ON (B)(6) 2018. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4). INVOLVED COMPONENTS: NN261Z (TIBIAL OBTURATOR D12MM, L7MM), NX043 (UNIVERSAL PATELLA P3), NX222 (PS PE INSERT T2/T2+, 14MM), NX009Z (PS FEMUR CEMENTED F4N LT). CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. ASSOCIATED MEDWATCHES: 2916714-2020-00422, 2916714-2020-00423, 2916714-2020-00424, 2916714-2020-00425, 2916714-2020-00426.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 11387862 ↗