AS VEGA System® PS NX007ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963809829), received between Feb 25, 2021 and Aug 14, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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.

• 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 replacement with the patella resurfaced. The femoral component appeared loose, with severe periprosthetic osteolysis about the femur. The patient was assessed with mechanical loosening and peripros

  Patient problems: Insufficient Information

  MAUDE report 50260356 ↗
• InjuryFeb 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND DIFFICULTY WALKING OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 REFERENCE XC (B)(4). INVOLVED COMPONENTS: NX007Z (PS FEMUR CEMENTED F3N LT); NN260P (PEEK PLUG F/ TIBIA); NX049Z (PS TIBIA CEMENTED T0); NX042 (UNIVERSAL PATELLA P2); NX102 (PS PE INSERT T0/T0+, 14MM). CEMENT USED IS UNKNOWN. ASSOCIATED MEDWATCHES: 2916714-2020-00313, 2916714-2020-00314, 2916714-2020-00315, 2916714-2020-00316.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11381276 ↗