VEGA System® PS+ NX230Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046963811242), received between Dec 15, 2020 and Jun 25, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED POSTOPERATIVE LOOSENING FOLLOWING A RIGHT TOTAL KNEE ARTHROPLASTY. ACCORDING TO THE AVAILABLE OPERATIVE REPORT, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022, FOR RIGHT KNEE TRICOMPARTMENTAL OSTEOARTHRITIS. THE PROCEDURE UTILIZED AESCULAP COMPONENTS WHICH WERE CEMENTED USING PALACOS BONE CEMENT. THE OPERATIVE REPORT DOCUMENTED THAT THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INTRAOPERATIVE COMPLICATIONS. TRIALING AND FINAL IMPLANTATION DEMONSTRATED FULL EXTENSION AND FLEXION, NO INSTABILITY, AND SATISFACTORY PATELLAR TRACKING. THE PATIENT WAS TAKEN TO RECOVERY IN GOOD CONDITION. THE OPERATIVE REPORT DID NOT DOCUMENT INTRAOPERATIVE EVIDENCE OF LOOSENING, DEVICE MALFUNCTION, OR OTHER DEVICE-RELATED COMPLICATIONS AT THE TIME OF THE INDEX PROCEDURE. A CLINIC NOTE DATED (B)(6) 2022 INDICATED THAT THE PATIENT'S RANGE OF MOTION WAS BACK TO 95 OR 100 BUT STATED THAT THE PATIENT STILL WALKED WITH A LIMP. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25621038 ↗
• InjuryJun 9, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS ASSOCIATED WITH A LEFT TOTAL KNEE REPLACEMENT (TKR). ACCORDING TO CLINICAL DOCUMENTATION, THE PATIENT INITIALLY UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6), 2022. FOLLOWING THE TOTAL KNEE REPLACEMENT, THE PATIENT EXPERIENCED PERSISTENT SYMPTOMS, INCLUDING PAIN, INSTABILITY, RECURRENT BUCKLING, AND LIMITED FUNCTION OF THE LEFT KNEE. AN OFFICE VISIT DATED (B)(6), 2023 DOCUMENTED 3+ EFFUSION AND LATERAL LAXITY, WITH CONCERN FOR INSTABILITY. DUE TO ONGOING SYMPTOMS, THE PATIENT UNDERWENT REVISION LEFT KNEE ARTHROPLASTY ON (B)(6), 2023. OPERATIVE FINDINGS INCLUDED LOOSENING OF THE TIBIAL COMPONENT WITH OBSERVED MICROMOTION. THE PROCEDURE INVOLVED REMOVAL OF THE LOOSENED COMPONENT AND IMPLANTATION OF A REVISED TIBIAL COMPONENT WITH POLYETHYLENE INSERT. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. THIS REPORT IS FILED UNDER AIS REFERENCE XC (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25443800 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED POST-OPERATIVE LOOSENING FOLLOWING A LEFT KNEE ARTHROPLASTY PROCEDURE THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2018, THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY FOR DEGENERATIVE JOINT DISEASE (DJD). THE PROCEDURE WAS PERFORMED USING CEMENTED COMPONENTS, AND THE OPERATIVE REPORT INDICATES THAT THE IMPLANTS WERE PLACED WITH APPROPRIATE ALIGNMENT AND STABILITY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED JULY 21, 2025, THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO FAILED PRIOR KNEE PROSTHESIS WITH LOOSENING OF COMPONENTS. INTRAOPERATIVELY, THE TIBIAL AND FEMORAL COMPONENTS WERE NOTED TO BE LOOSE AND WERE REMOVED WITHOUT DIFFICULTY. REVISION COMPONENTS WERE IMPLANTED USING BONE CEMENT, AND TRIALING DEMONSTRATED STABILITY THROUGH RANGE OF MOTION WITHOUT VARUS OR VALGUS LAXITY. THE OPERATIVE REPORT INDICATES THAT THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION AND NO INTRAOPERATIVE COMPLICATI

  Patient problems: Failure of Implant

  MAUDE report 24649231 ↗
• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE LEFT KNEE FOR LOOSENING OF PRIOR COMPONENTS. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION KNEE SURGERY FOR A LOOSE PATELLAR BUTTON. THE PATELLAR BUTTON WAS REMOVED EASILY WITH A RONGEUR AND OSTEOTOME. A NEW PATELLAR BUTTON WAS NOT IMPLANTED DUE TO INADEQUATE BONE STOCK AND RISK OF LOOSENING. THE FEMORAL AND TIBIAL COMPONENTS WERE ASSESSED AND APPEARED STABLE. THE JOINT WAS IRRIGATED, VANCOMYCIN POWDER WAS PLACED INTRA-ARTICULARLY, AND THE CAPSULE WAS CLOSED. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION. ON (B)(6) 2024, THE PATIENT RETURNED WITH EVIDENCE OF FEMORAL AND TIBIAL COMPONENT LOOSENING. A MIDLINE INCISION AND MEDIAL PARAPATELLAR APPROACH WERE USED. THE TIBIAL COMPONENT WAS REMOVED AFTER CEMENT AT THE BONE INTERFACE WAS DISRUPTED AND THE IMPLANT WAS KNOCKED FREE. THE FEMORAL COMPONENT WAS THEN REMOVED WITH USE OF A SAW AND OSTEOTOME AFTER CIRCUMFERENTIAL RELEASE. APPROXIMATELY ONE-THIRD OF THE FEMUR WAS LOST DURING REMOVAL. AN ANTIBIOTIC-IMPREGNATED SPACER WAS IMPLANTED, AND THE JOINT WAS CLOSED FOLLOWING IRRIGATION AND VANCOMYCIN POWDER APPLICATION. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE COND

  Patient problems: Failure of Implant

  MAUDE report 22993986 ↗
• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  UPDATE: REVISION SURGERY AND IMPLANTATION OF NON-AESCULAP DEVICES WAS PERFORMED ON (B)(6) 2025. ONTRACTURE OF THE RIGHT KNEE AND ANKYLOSIS POSTOPERATIVELY WAS FOUND, AND MANIPULATION OF THE KNEE JOINT UNDER GENERAL ANESTHESIA WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Failure of Implant

  MAUDE report 22993251 ↗
• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE RIGHT KNEE FOR LOOSENING OF PRIOR COMPONENTS. THE FEMORAL COMPONENT WAS REMOVED USING A MICROCHOICE AND OSTEOTOME WITH MINIMAL BONE LOSS. THE TIBIA WAS SUBLUXED FORWARD AND A MICROCHOICE WAS USED ABOUT THE PROSTHESIS TO LOOSEN IT. THE TIBIAL COMPONENT WAS ABLE TO BE REMOVED WITH MINIMAL BONE LOSS. TRIAL COMPONENTS WERE PLACED, AND STABLE FIXATION WITH ACCEPTABLE FLEXION/EXTENSION WAS ACHIEVED. A POLYETHYLENE INSERT WAS PLACED, AND THE JOINT WAS COPIOUSLY IRRIGATED. THE PATIENT TOLERATED THE PROCEDURE, WAS AWAKENED FROM ANESTHESIA, AND TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 22992548 ↗
• InjuryJul 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA PS+ GLIDING SURFACE T3/3+ 10MM (PART # NX230) WAS IMPLANTED ON A UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT A REVISION SURGERY WAS NECESSARY DUE TO POSTOPERATIVE DEVICE INTERACTION PROBLEM. THE REVISION WAS PLANNED FOR (B)(6) 2024. THE POLYETHYLENE COMPONENT WOULD BE REMOVED AND REPLACED. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 19700118 ↗
• InjuryJun 18, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO CHANGES REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025271 ↗
• InjuryJun 18, 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 PS+ GLIDING SURFACE T3/3+ 10MM (PART # NX230) WAS IMPLANTED DURING A TOTAL KNEE REPLACEMENT SURGICAL PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SCREW FOR VEGA PS POLY BACKED OUT AND BECAME LOOSE IN THE JOINT. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FOLLOWUP INFORMATION WAS RECEIVED WHICH CONFIRMED THAT THE DEVICE DID NOT BREAK; THE SCREW BACKED OUT. THE PATIENT UNDERWENT A 25 MINUTE SCOPE PROCEDURE WHILE UNDER ANESTHESIA TO REMOVE THE SCREW. NO PATIENT COMPLICATION WERE REPORTED AS A RESULT OF THE EVENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024924 ↗
• 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, 2916714-2020-00287, 2916714-2020-00288, 2916714-2020-00289, 2916714-2020-00290.

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

  MAUDE report 11008088 ↗