AS VEGA System® PS NX029ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046963810122), received between Mar 5, 2019 and Aug 14, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Patient-Device Incompatibility

  An outside law firm reported that a patient experienced postoperative loosening and instability following a right total knee arthroplasty. According to the available medical records, the patient underwent a right total knee arthroplasty on (b)(6) 2021. The patient subsequently developed loosening of the right total knee arthroplasty with gross instability. On December 23, 2024, the patient underwent revision right total knee arthroplasty involving the femoral and tibial components. The preoperative and postoperative diagnoses were documented as right knee loose total knee arthroplasty with gross instability. During the revision procedure, the femoral component was visualized and reportedly came right off when grasped. The tibial prosthesis was loosened and removed easily with minimal bone loss. The patellar button was also assessed intraoperatively and was documented to be loose. The femur and tibia were prepared for revision components. Following trialing, the knee demonstrated full range of motion with excellent stability to varus and valgus stress. The revision components were cemented into place using a third-generation cement technique. The patient was awakened from surgery an

  Patient problems: Insufficient Information

  MAUDE report 50260854 ↗
• 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 25055702 ↗
• InjuryJun 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2020, THE PATIENT UNDERWENT RIGHT KNEE MANIPULATION UNDER ANESTHESIA FOR RIGHT KNEE STIFFNESS AFTER TOTAL KNEE ARTHROPLASTY (TKA). ON (B)(6) 2023, THE PATELLAR BUTTON WAS REPLACED DUE TO ASEPTIC LOOSENING. FINDINGS DURING THE REVISION ON (B)(6) 2025 INCLUDED DEBONDING OF CEMENT FROM TIBIA AND FEMUR, GROSSLY LOOSE TIBIA AND FEMUR; NON-AESCULAP IMPLANTS WERE USED INSTEAD. ANOTHER RIGHT KNEE MANIPULATION UNDER ANESTHESIA FOR RIGHT KNEE STIFFNESS WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Failure of Implant

  MAUDE report 22206548 ↗
• InjuryJun 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 (B)(6) , 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 COMPONE

  Patient problems: Failure of Implant

  MAUDE report 22205721 ↗
• InjuryOct 6, 2023Loosening 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 SYSTEM (PART # UNKNOWN) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINT THERE WAS A POSTOPERATIVE LOOSENING OF THE IMPLANT. X RAYS SHOW THAT THE CEMENT DID NOT ADHERE TO THE IMPLANTS OR THE BONE. REPORTEDLY THE PATIENT COMPLAINED OF RIGHT KNEE PAIN AFTER THE INITIAL PROCEDURE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). REFERENCE ASSOCIATED MEDWATCH REPORTS: (B)(4) (2916714-2023-00092) (B)(4). (B)(4) (2916714-2023-00094) (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17884977 ↗
• InjuryOct 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS VEGA PS FEMORAL COMP.CEMENTED F4N R (PART # NX029Z) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED IN 2018. ACCORDING TO THE COMPLAINANT, THERE WAS POSTOPERATIVE LOOSENING OF THE IMPLANT. THIS OCCURRED DUE TO A PATIENT FALL. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION WAS REQUIRED; COLUMBUS REVISION PRODUCTS WERE IMPLANTED. FURTHER DETAILS HAVE BEEN REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE 400569176. ASSOCIATED MEDWATCH REPORT: (B)(4) 2916714-2022-00101.

  Patient problems: Bone Fracture(s)

  MAUDE report 15546409 ↗
• InjuryOct 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP AG THAT AN AS VEGA PS FEMORAL COMP.CEMENTED F4N R (PART # NX029Z) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED IN 2018. ACCORDING TO THE COMPLAINANT, THERE WAS POSTOPERATIVE LOOSENING OF THE IMPLANT. THIS OCCURRED DUE TO A PATIENT FALL. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION WAS REQUIRED; COLUMBUS REVISION PRODUCTS WERE IMPLANTED. FURTHER DETAILS HAVE BEEN REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORT: (B)(4) (9610612-2022-00281) NX053Z.

  Patient problems: Failure of Implant

  MAUDE report 15539981 ↗
• InjurySep 9, 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 NX029Z - AS VEGA PS FEMORAL COMP.CEMENTED F4N R. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING EXPLANT OF THE PRIMARY KNEE COMPONENTS, THE FEMUR CAME RIGHT OFF AND SURGEON NOTICED THAT THERE WAS NOT MUCH BONE CEMENT ADHERED TO THE FEMORAL COMPONENT. ONLY A COUPLE OF SMALL PATCHES OF CEMENT COULD BE SEEN ON THE POSTERIOR CONDYLES. NO CEMENT VISIBLE ON ANY OTHER PART OF COMPONENT. ALL BONE CEMENT WAS ONLY ADHERED TO THE BONE ON THE FEMUR. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX125 - VEGA PS GLIDING SURFACE T2/2+ 20MM - LOT UNKNOWN , NX053Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T2 - LOT 52542951.

  Patient problems: Failure of Implant

  MAUDE report 12450636 ↗
• InjurySep 9, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INVOLVED COMPONENTS NX125 - VEGA PS GLIDING SURFACE T2/2+ 20MM - LOT UNKNOWN NX053Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T2 - LOT 52542951

  Patient problems: Failure of Implant

  MAUDE report 12450555 ↗
• InjuryApr 15, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4) ((B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 11673335 ↗
• InjuryMar 5, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL EVENT DETAILS: PER THE REPORTER, THE PATIENT EXPERIENCED SYMPTOMS OF PAIN AND STIFFNESS AND FELT LIKE THE IMPLANT WAS MOVING. THE REVISION SURGERY WENT WELL AND WAS COMPLETED ON (B)(6) 2019 WITH NO X-RAYS TAKEN DURING THE SURGICAL PROCEDURE. IT WAS A ROUTINE REVISION.

  Patient problems: Failure of Implant; Joint Disorder

  MAUDE report 8392627 ↗