AS VEGA System® PS NX058ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963810511), received between Nov 9, 2020 and Aug 27, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 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 22903556 ↗
• 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, 2916714-2020-00587.

  Patient problems: Pain

  MAUDE report 10813459 ↗