AS VEGA System® PS NX054ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046963810436), received between Oct 8, 2020 and Apr 27, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 24998745 ↗
• InjuryMar 16, 2026Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT, ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION ARTHROPLASTY OF THE RIGHT KNEE DUE TO A FAILED UNICOMPARTMENTAL KNEE REPLACEMENT. DURING THE PROCEDURE, THE COMPONENTS WERE EXPOSED AND REMOVED, AND THE KNEE WAS CONVERTED TO A TOTAL KNEE ARTHROPLASTY. TRIAL COMPONENTS DEMONSTRATED APPROPRIATE ALIGNMENT AND STABILITY. THE FINAL COMPONENTS WERE IMPLANTED USING BONE CEMENT. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION WITH NO INTRAOPERATIVE COMPLICATIONS REPORTED. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT UNDERWENT AN ADDITIONAL REVISION PROCEDURE OF THE RIGHT KNEE. DURING THE PROCEDURE, THE EXISTING COMPONENTS AND RESIDUAL CEMENT WERE REMOVED. THE FEMUR AND TIBIA WERE PREPARED, AND NEW COMPONENTS WERE IMPLANTED WITH BONE CEMENT. TRIALING DEMONSTRATED STABILITY THROUGH RANGE OF MOTION WITH NO VARUS OR VALGUS LAXITY AND APPROPRIATE PATELLAR TRACKING. THE WOUND WAS CLOSED AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 24604761 ↗
• InjuryOct 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  UPDATE: ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT HAD COMPLAINED OF PAIN AND STIFFNESS OF THE RIGHT KNEE POSTOPERATIVELY. A REVISION WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT WAS STILL OUT OF WORK AND ATTENDING PHYSICAL THERAPY.

  Patient problems: Failure of Implant

  MAUDE report 23211173 ↗
• InjuryFeb 18, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE IMPLANT FAILED TO PROPERLY REACT WITH THE PALACOS MV WITH ANTIBIOTIC CEMENT USED FOR FIXATION. THE PATIENT WILL UNDERGO A REVISION SURGERY OF THE RIGHT KNEE. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345115 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED OF KNEE PAIN. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Pain

  MAUDE report 11344418 ↗
• InjuryFeb 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO UPDATES.

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

  MAUDE report 11310961 ↗
• InjuryDec 17, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  NO UPDATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11032142 ↗
• InjuryDec 17, 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 NX054Z AS VEGA PS TIBIAL PLATEAU CEMENTED T2+. THE ORIGINAL IMPLANTS HAD BEEN A VEGA KNEE SYSTEM, WHICH LATER REQUIRED TIBIA REVISION. THIS INITIAL PROCEDURE OCCURRED IN (B)(6) 2017. IT WAS NOTED THAT NO CEMENT ADHERED TO THE BASEPLATE. THE CEMENT MANTLE WAS STILL COMPLETE ON TIBIA. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4). INVOLVED COMPONENTS: NX221 - VEGA PS+ GLIDING SURFACE T2/2+ 12MM, 52351863. PALACOS R CEMENT.

  Patient problems: Failure of Implant

  MAUDE report 11031997 ↗
• InjuryNov 10, 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 PAIN AND SWELLING IN BOTH KNEES; NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2012, AND THE REVISION WAS PERFORMED ON (B)(6) 2016. INTRAOPERATIVE FINDINGS WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX031Z (PS FEMUR CEMENTED F5N RT). NX043 (UNIVERSAL PATELLA P3). NX054Z (PS TIBIA CEMENTED T2+). NX120 (PS PE INSERT T2/T2+, 10MM). NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS NOT SPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE XC 100026350. ASSOCIATED MEDWATCHES: 2916714-2020-00495, 2916714-2020-00496, 2916714-2020-00498, 2916714-2020-00499.

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

  MAUDE report 10816403 ↗
• InjuryOct 8, 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, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013, AND THERE WAS NO REPORTED REVISION SURGERY. 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: NX054Z; (PS TIBIA CEMENTED T2+); NX044; (UNIVERSAL PATELLA P4); NX120; (PS PE INSERT T2/T2+, 10MM); NX011ZP; (PS FEMUR CEMENTED F5N LT); NN260P; (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00461; 2916714-2020-00462; 2916714-2020-00463; 2916714-2020-00464.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10652456 ↗