AS VEGA System® PS NX057ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046963810498), received between Apr 3, 2018 and Aug 14, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 5 most recent of 5 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 loosening of the left knee prosthesis. According to the available medical records, the patient underwent a left total knee arthroplasty on (b)(6) 2022, for left knee osteoarthritis. The procedure utilized an Aesculap Vega system. The operative report documented that the procedure was completed without reported intraoperative complications. Intraoperative trialing demonstrated full extension and flexion with appropriate patellar tracking. The implants were placed using third-generation cement technique, and the patient was taken to the post-anesthesia care unit in stable condition. On (b)(6) 2026, the patient was evaluated for left knee pain. The assessment included mechanical loosening of the internal left knee prosthetic joint. A triple-phase bone scan was reported as normal with no prosthetic loosening, fracture, or osteomyelitis; however, the treating physician documented disagreement with the radiology interpretation, noting increased uptake along the patellar component and underneath the femoral component. The patient was reportedly tender in this area, and the physician documented that the findings were consistent with l

  Patient problems: Insufficient Information

  MAUDE report 50258558 ↗
• InjuryAug 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE RIGHT KNEE FOR LOOSENING AND FAILURE OF PRIOR COMPONENTS. THE FEMORAL COMPONENT WAS REMOVED WITH MICRO-OSTEOTOME TECHNIQUES. THE TIBIA DEMONSTRATED MEDIAL-SIDED COLLAPSE AND WAS REAMED/BROACHED TO APPROPRIATE SIZE. TRIAL COMPONENTS WERE PLACED, AND STABLE FIXATION WITH ACCEPTABLE FLEXION/EXTENSION WAS ACHIEVED. FINAL FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED USING THIRD-GENERATION CEMENT TECHNIQUE. 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 22903547 ↗
• InjuryMar 8, 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 TIBIAL PLATEAU CEMENTED T4 (PART # NX057Z) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, POST-OPERATION EARLY LOOSENING OF KNEE TEP IMPLANT. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX140 - VEGA PS GLIDING SURFACE T4/4+ 10MM - LOT 52437122. NX014Z - AS VEGA PS FEMORAL COMP.CEMENTED F6L - LOT 52344340.

  Patient problems: Failure of Implant

  MAUDE report 13699411 ↗
• InjuryNov 9, 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 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) 2017 AND THERE WAS NO REPORTED REVISION SURGERY. CEMENT USED: DEPURY SMARTSET GHV BONE CEMENT. 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: NN264Z (TIBIAL OBTURATOR D14MM L7MM). NX057Z (PS TIBIA CEMENTED T4). NX033Z (PS FEMUR CEMENTED F6N RT). NX240(PS+PE INSERT T4/T4+,10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00565. 2916714-2020-00567. 2916714-2020-00568.

  Patient problems: Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 10812167 ↗
• MalfunctionApr 3, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  COUNTRY OF COMPLAINT: USA. RECEIVED VIA MEDWATCH (MW5075187): EVENT DESCRIPTION PER MW REPORT: GLOBAL FAILURE TOTAL KNEE REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FILE WILL BE UPDATED WHEN INFORMATION IS RECEIVED. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00145.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7394115 ↗