AS VEGA System® PS NX052ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046963810399), received between Oct 12, 2021 and Jun 8, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS WITH AN AESCULAP KNEE IMPLANT. REPORTEDLY THE FEMORAL COMPONENT WAS "GROSSLY LOOSE" AND "REMOVED BY HAND". THE TIBIAL COMPONENT WAS ALSO "GROSSLY LOOSE" AND "LIFTED OUT OF THE CEMENT MANTLE" THE CEMENT MANTLE REMAINED ADHERED TO THE BONES AND HAD TO BE EXTRACTED DURING THE REVISION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25431192 ↗
• InjuryMay 1, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES FOLLOWING A LEFT KNEE PROSTHESIS. ACCORDING TO AVAILABLE RECORDS, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, FOR DEGENERATIVE JOINT DISEASE. SUBSEQUENTLY, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021. BOTH PROCEDURES WERE REPORTED TO BE COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POSTOPERATIVELY, THE PATIENT INITIALLY REPORTED IMPROVEMENT. AT FOLLOW-UP ON (B)(6) 2021, THE PATIENT WAS NOTED TO BE DOING WELL WITHOUT PAIN OR COMPLAINTS. ON (B)(6) 2022, THE PATIENT REPORTED A FALL WITH SUBSEQUENT LEFT KNEE PAIN, DECREASED RANGE OF MOTION, AND INSTABILITY. IMAGING AND CLINICAL FINDINGS AT THAT TIME NOTED DEGENERATIVE CHANGES AND LIGAMENTOUS LAXITY. THE PATIENT CONTINUED TO REPORT PERSISTENT KNEE SYMPTOMS DESPITE CONSERVATIVE MANAGEMENT, INCLUDING INJECTIONS. ON (B)(6) 2022, THE PATIENT REPORTED ONGOING KNEE PAIN; IMAGING AT THAT TIME DID NOT DEMONSTRATE LOOSENING. AT FOLLOW-UP ON (B)(6) 2026, IMAGING DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH FINDINGS OF MECHANICAL LOOSENING OF THE FEMORAL COMPONENT, ASSOCIATED LUCENCY, AND INSTABILITY. CLINICAL EXAMIN

  Patient problems: Failure of Implant

  MAUDE report 25055703 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS FOLLOWING A RIGHT KNEE PROSTHESIS THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2021, THE PATIENT UNDERWENT A PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY FOR TRICOMPARTMENTAL DEGENERATIVE JOINT DISEASE (DJD) WITH VARUS DEFORMITY. THE PROCEDURE WAS PERFORMED USING AESCULAP VEGA COMPONENTS, WHICH WERE CEMENTED IN PLACE USING PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THAT THE COMPONENTS WERE IMPLANTED WITH APPROPRIATE ALIGNMENT AND STABILITY, WITH CENTRAL PATELLAR TRACKING AND NO EVIDENCE OF VARUS OR VALGUS INSTABILITY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO RECOVERY IN GOOD CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED JUNE 30, 2025, THE PATIENT UNDERWENT A REVISION RIGHT TOTAL KNEE ARTHROPLASTY DUE TO FAILURE OF THE PRIOR KNEE REPLACEMENT WITH LOOSENING OF COMPONENTS. INTRAOPERATIVELY, BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE NOTED TO BE LOOSE WITH FRAGMENTATION OF CEMENT AND WERE REMOVED WITHOUT SIGNIFICANT DIFFICULTY. REVISION WAS PERFORMED USING ANOTHER MANUFACTURER'S COMPONENTS

  Patient problems: Failure of Implant

  MAUDE report 24653690 ↗
• InjuryOct 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NX052Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T1+. ACCORDING TO THE COMPLAINT DESCRIPTION, PATIENT UNDERWENT REVISION SURGERY 1 YEAR 10 MONTHS POST SURGERY DUE TO LOOSENING OF TIBIA IMPLANT. INITIAL SURGERY: (B)(6) 2018. REVISION SURGERY: (B)(6) 2021. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NN261Z - AS TIBIAL OBTURATOR D12MM - LOT 52393406. NX110 - VEGA PS GLIDING SURFACE T1/1+ 10MM - LOT 52396660. NX009Z - AS VEGA PS FEMORAL COMP.CEMENTED F4N L - LOT 52357510.

  Patient problems: Failure of Implant

  MAUDE report 12618323 ↗