AS VEGA System® PS NX030ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963810146), received between Dec 15, 2020 and Jul 15, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS VEGA PS FEMORAL COMP CEMENTED F4R (PART # NX030Z) WAS IMPLANTED ON (B)(6) 2019. ACCORDING TO THE COMPLAINT DESCRIPTION, THIS KNEE IMPLANT WAS "DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT". THERE WAS POSTOPERATIVE MECHANICAL LOOSENING. IT WAS NOTED THAT THE SURGEON EASILY REMOVED THE IMPLANT BY HAND DURING THE REVISION. THE PATIENT WAS REVISED TO A PRODUCT FROM A DIFFERENT MANUFACTURER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 22506068 ↗
• InjuryMar 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT. AFTER FIRST REVISION SURGERY, PATIENT CONTINUED TO EXPERIENCE PAIN, SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A SECOND REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, WITH FIRST REVISION IN (B)(6) 2015, WITH ANOTHER VEGA IMPLANT. THE SECOND REVISION SURGERY OCCURRED ON (B)(6) 2017, WITH AN UNIDENTIFIED NON-AESCULAP IMPLANT.. 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: NX030Z (PS FEMUR CEMENTED F4 RT) NN264Z (TIBIAL OBTURATOR D14MM, L7MM) NX043 (UNIVERSAL PATELLA P3) NX056Z (PS TIBIA CEMENTED T3+) NX132 (PS PE INSERT T3/T3+, 14MM) THE COMPONENTS LISTED ARE RELATED TO THE PRIMARY SURGERY. IT IS UNKNOWN EXACTLY WHICH COMPONENTS WERE REPLACED IN THE FIRST AND SECOND REVISION S

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

  MAUDE report 11423373 ↗
• InjuryDec 15, 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 COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING AND LOSS OF MOBILITY WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2015. 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 (B)(4). INVOLVED COMPONENTS: NX043 (UNIVERSAL PATELLA P3), NX030Z(PS FEMUR CEMENTED F4 RT), NX230 (PS PE INSERT T3/T3+, 10MM), NX055Z (PS TIBIA CEMENTED T3), NX062Z(TIBIAL STEM CEMENTED 12X52MM). THE CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00286, 2916714-2020-00288, 2916714-2020-00289, 2916714-2020-00290.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Swelling/ Edema

  MAUDE report 11008044 ↗