VEGA System® PS+ NX220Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04046963811181), received between Nov 6, 2020 and Jun 30, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ISSUES WITH A LEFT KNEE PROSTHESIS. ACCORDING TO THE OPERATIVE REPORT, A PATIENT WITH A HISTORY OF BILATERAL KNEE DEGENERATIVE JOINT DISEASE AND PRIOR TOTAL KNEE ARTHROPLASTIES PRESENTED WITH ONGOING MUSCULOSKELETAL COMPLAINTS. THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2021 WITHOUT INTRAOPERATIVE COMPLICATIONS. SUBSEQUENTLY, AFTER A MOTOR VEHICLE ACCIDENT IN (B)(6) 2022, THE PATIENT REPORTED NECK, BACK, HIP, AND LEFT KNEE PAIN. IMAGING AT THAT TIME DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH NORMAL ALIGNMENT AND NO EVIDENCE OF LOOSENING OR INSTABILITY. ACCORDING TO THE MEDICAL RECORDS, FOLLOWING THE ACCIDENT, THE PATIENT REPORTED PERSISTENT LEFT LOWER EXTREMITY PAIN WITH RADIATION IN AN S1 DISTRIBUTION, NUMBNESS, AND ONGOING DISCOMFORT. AN ORTHOPEDIC EVALUATION DATED (B)(6) 2022, DOCUMENTED PAIN AND DISCOMFORT INVOLVING THE LEFT LEG IN THE S1 DISTRIBUTION. PHYSICAL EXAMINATION DEMONSTRATED A POSITIVE STRAIGHT LEG RAISE ON THE LEFT AT 45 DEGREES WITH DECREASED SENSATION OVER THE LATERAL THREE TOES. AT THIS TIME, THE PATIENT HAS NOT BEEN SCHEDULED TO UNDERGO A REVISION PROCEDURE. THE EVENT

  Patient problems: External Prosthetic Device Pain

  MAUDE report 25668988 ↗
• InjuryApr 27, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES FOLLOWING A LEFT KNEE PROSTHESIS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2020 FOR DEGENERATIVE JOINT DISEASE. THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POSTOPERATIVELY, THE PATIENT REPORTED PERSISTENT LEFT KNEE PAIN DESPITE CONSERVATIVE MANAGEMENT, INCLUDING PHYSICAL THERAPY AND CORTICOSTEROID INJECTIONS. CLINICAL NOTES DOCUMENT CONTINUED PAIN IN MULTIPLE REGIONS OF THE KNEE. BONE SCAN IMAGING LATER DEMONSTRATED INCREASED ACTIVITY AT THE TIP OF THE LEFT TIBIAL STEM WITH ASSOCIATED PAIN, NOTED AS POSSIBLY REPRESENTING LOOSENING OR PHYSIOLOGIC CHANGE. AT FOLLOW-UP ON (B)(6) 2026, IMAGING DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH LUCENCY AT THE FEMORAL COMPONENT (POSTERIOR CUT) AND THE FEMORAL COMPONENT APPEARING LOOSE. CLINICAL FINDINGS INCLUDED PAIN AND SUPRAPATELLAR CLUNK, WITH DIAGNOSES OF MECHANICAL LOOSENING AND INSTABILITY OF THE LEFT KNEE PROSTHETIC JOINT. NO REVISION SURGERY OR INFECTION WAS DOCUMENTED IN THE AVAILABLE RECORDS. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24998405 ↗
• InjuryApr 27, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES FOLLOWING A RIGHT KNEE PROSTHESIS. ACCORDING TO THE OPERATIVE REPORT, A PATIENT WITH A HISTORY OF BILATERAL KNEE DEGENERATIVE JOINT DISEASE AND PRIOR TOTAL KNEE ARTHROPLASTIES PRESENTED WITH ONGOING MUSCULOSKELETAL COMPLAINTS. THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2016 WITHOUT INTRAOPERATIVE COMPLICATIONS. SUBSEQUENTLY, AFTER A MOTOR VEHICLE ACCIDENT IN (B)(6) 2022, THE PATIENT REPORTED NECK, BACK, HIP, AND LEFT KNEE PAIN. IMAGING AT THAT TIME DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH NORMAL ALIGNMENT AND NO EVIDENCE OF LOOSENING OR INSTABILITY. THE PATIENT CONTINUED TO REPORT LEFT LOWER EXTREMITY PAIN WITH RADICULAR SYMPTOMS. AT A LATER FOLLOW-UP ON (B)(6) 2025, THE PATIENT PRESENTED WITH RIGHT KNEE PAIN AND LAXITY. IMAGING FINDINGS SUGGESTED LOOSENING OF THE RIGHT KNEE PROSTHESIS WITH SUSPECTED COMPONENT FAILURE, AND ADDITIONAL IMAGING WAS PLANNED FOR FURTHER EVALUATION. A CLINIC NOTE DATED (B)(6) 2026 DOCUMENTED PERSISTENT RIGHT KNEE PAIN THAT HAD NOT IMPROVED WITH INJECTIONS OR PHYSICAL THERAPY. THE EVENT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24997871 ↗
• InjuryMar 30, 2026Patient-Device Incompatibility

  The patient underwent revision left total knee arthroplasty on (b)(6) 2025 due to a loose total knee arthroplasty with gross instability.During revision surgery, the surgeon documented gross loosening of both the femoral and tibial components of the implanted Aesculap Vega knee system. The surgeon noted that the cement had completely debonded from both the femoral and tibial implants. The debonding was so pronounced that the implant imprints remained visible in the intact cement mantle following implant removal.The surgeon reported that the femoral component was grossly loose and could be removed with a periosteal elevator. The tibial component was also grossly loose and was easily removed with a periosteal elevator. The patellar button was additionally found to be loose and was removed. The event required revision total knee arthroplasty involving femoral and tibial component revision and patellar button removal. No intraoperative complications were reported. Patient was transferred to PACU in stable condition following revision surgery.The adverse event is filed under AIS reference (b)(4).

  Patient problems: Failure of Implant

  MAUDE report 24731193 ↗
• InjuryMar 25, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS FOLLOWING A LEFT KNEE PROSTHESIS THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2022, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA) FOR OSTEOARTHRITIS. THE PROCEDURE WAS PERFORMED USING CEMENTED KNEE COMPONENTS (AESCULAP SYSTEM) WITH PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO INTRAOPERATIVE COMPLICATIONS, AND THE IMPLANTS WERE PLACED WITH APPROPRIATE ALIGNMENT AND STABILITY. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED PERSISTENT STIFFNESS, PAIN, AND REDUCED RANGE OF MOTION. ON (B)(6) 2022, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA, JOINT ASPIRATION, AND FEMORAL NERVE INJECTION DUE TO CONTINUED STIFFNESS. SYMPTOMS PERSISTED DESPITE INTERVENTION. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED (B)(6) 2023, THE PATIENT UNDERWENT A REVISION PROCEDURE WITH TIBIAL COMPONENT REVISION AND POSTERIOR CAPSULAR RELEASE DUE TO ARTHROFIBROSIS AND STIFFNESS. ACCORDING TO A LATER OPERATIVE REPORT DATED (B)(6) 2024, THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENIN

  Patient problems: Failure of Implant

  MAUDE report 24687121 ↗
• InjuryMar 23, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ISSUES FOLLOWING A LEFT KNEE PROSTHESIS THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2022, A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. THE PROCEDURE WAS PERFORMED USING CEMENTED KNEE COMPONENTS (AESCULAP SYSTEM) WITH PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO INTRAOPERATIVE COMPLICATIONS, AND THE IMPLANTS WERE PLACED WITH APPROPRIATE ALIGNMENT AND STABILITY. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED (B)(6) 2023, THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. INTRAOPERATIVELY, BOTH COMPONENTS WERE NOTED TO BE GROSSLY LOOSE, WITH NO CEMENT ADHERENT TO THE IMPLANTS. THE COMPONENTS WERE REMOVED WITHOUT SIGNIFICANT BONE LOSS. REVISION WAS PERFORMED USING STEMMED FEMORAL AND TIBIAL COMPONENTS, BONE CEMENT, AND ADJUNCTIVE MATERIALS INCLUDING ANTIBIOTIC BEADS. FINAL IMPLANTATION DEMONSTRATED STABLE FIXATION WITH APPROPRIATE ALIGNMENT AND FULL RANGE OF MOTION WITHOUT INSTABILITY. THE PATIENT TOLERATED THE PROCEDURE AND W

  Patient problems: Failure of Implant

  MAUDE report 24661554 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  ACCORDING TO THE EVENT DESCRIPTION: A PATIENT ALLEGES POST-OPERATIVE LOOSENING OF AESCULAP KNEE IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 24575853 ↗
• InjurySep 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED WITH ARTHROFIBROSIS AND LOOSENING OF A PRIOR LEFT TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE FEMUR AND TIBIA FOR INSTABILITY AND FAILED FIXATION. INTRAOPERATIVELY, BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO BE LOOSE WITH MINIMAL CEMENT ADHESION. A LARGE LATERAL CONDYLE BONE CYST AND OSTEOPOROTIC BONE WERE ALSO NOTED. THE FEMORAL COMPONENT WAS REMOVED WITH MICROCHOICE INSTRUMENTS AND MINIMAL BONE LOSS; THE TIBIAL COMPONENT WAS SIMILARLY LOOSE AND EASILY REMOVED. EXCESS SYNOVIUM WAS EXCISED. THE FEMUR AND TIBIA WERE RE-PREPARED. AN INTRAMEDULLARY GUIDE WAS PLACED, AND TRIALING CONFIRMED ALIGNMENT, RANGE OF MOTION, AND STABILITY. FINAL COMPONENTS WERE IMPLANTED USING THIRD-GENERATION CEMENT TECHNIQUE. A POLYETHYLENE INSERT WAS PLACED, AND STABILITY WAS CONFIRMED WITH VARUS/VALGUS STRESS AND FULL RANGE OF MOTION TESTING. VANCOMYCIN POWDER WAS APPLIED, THE WOUND WAS COPIOUSLY IRRIGATED, AND THE CAPSULE AND SKIN WERE CLOSED IN LAYERS. A STERILE DRESSING AND ACE WRAP WERE APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 23003379 ↗
• InjuryNov 6, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA KNEE IMPLANT SYSTEM, COMPRISED OF THE FOLLOWING COMPONENTS, VEGA SYSTEM PS FEMUR F5N LEFT (PART #NX011Z) (REF. ASSOCIATED MDR ID 2916714-2020-00536), VEGA SYSTEM TIBIA OBTURATOR 12MM T1-T3+ (PART # NN261Z) (REF. ASSOCIATED MDR ID 2916714-2020-00537), A VEGA SYSTEM PS TIBIA PLATEAU T2, CEMENTED IMPLANT (PART # NX053Z) (REF. ASSOCIATED MDR ID 2916714-2020-00538), AND A VEGA SYSTEM PS+ GLIDING SURFACE IMPLANT 10MM T2/T2+ (PART # NX220), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING & INSTABILITY OF THE IMPLANT, WHICH RESULTED IN A REVISION SURGERY BEING PERFORMED ON (B)(6) 2018. THE CEMENT USED DURING THE PRIMARY SURGERY IS UNKNOWN. NO KNOWN ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE REVISION SURGERY. THE COMPLAINT DEVICE IS 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). INVOLVED COMPONENTS: NX011Z - VEGA SYSTEM PS

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10803605 ↗