AS VEGA System® PS NX034ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963810221), received between Nov 9, 2020 and Sep 5, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2024Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION REPORTED THAT THE REASON FOR THE SURGERY WAS DUE TO A SCREW COMING LOSE IN THE CONSTRUCT, AS SUCH, THE IMPLANT WAS FLOATING AROUND IN THE JOINT. THE ADVERSE EVENT IS FILED UNDER AESCULAP REFERENCE NUMBER (B)(4). 2916714-2024-00130 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00148 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00149 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00150 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 20143995 ↗
• InjuryNov 9, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN AND INSTABILITY. THE PATIENT CLAIMED TO HAVE BEEN ABLE TO HEAR "RATTLING" SOUNDS POSTOPERATIVELY; RESULTS OF X-RAYS SHOWED LOOSENING OF THE IMPLANT. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2015, AND THE REVISION WAS PERFORMED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS WERE LOOSENING OF THE TIBIAL KEEL AND FEMORAL COMPONENT. SURGICAL CEMENT CONTINUED TO ADHERE TO THE BONE BUT HAD NOT ADHERED TO THE IMPLANT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NN484 (COLUMBUS PRI/REV PE PATELLA 3-PEGS P4), NX058Z (PS TIBIA CEMENTED T4+), NX140 (PS PE INSERT T4/T4+, 10MM), NN264Z (TIBIAL OBTURATOR D14MM, L7MM), NX034Z (PS FEMUR CEMENTED F6 RT). THE CEMENT USED WAS NOT SPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00583, 2916714-2020-00584, 2916714-2020-00585, 2916714-2020-00586.

  Patient problems: Pain

  MAUDE report 10813576 ↗