AS NX062ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046963810559), received between Dec 15, 2020 and Aug 14, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 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 50258559 ↗
• 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 24570629 ↗
• InjurySep 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  UPDATE: THERE HAD BEEN POSTOPERATIVE STIFFNESS IN 2022. ON (B)(6) 2023, REPLACEMENT OF THE GLIDING SURFACE IN THE LEFT KNEE WAS PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 23003378 ↗
• InjurySep 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE RIGHT KNEE FOR LOOSENING OF PRIOR COMPONENTS. A MIDLINE INCISION AND MEDIAL PARAPATELLAR APPROACH WERE PERFORMED, AND THE FEMORAL AND TIBIAL BONE WERE PREPARED USING STANDARD INSTRUMENTS. THE FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED USING THIRD-GENERATION CEMENT TECHNIQUE (VACUUM SEALED). A TIBIAL TRAY AND POLYETHYLENE INSERT WERE PLACED, FOLLOWED BY PATELLAR BUTTON PLACEMENT. DURING THE PROCEDURE, BONE CUTS, TRIALING, AND IMPLANTATION PROCEEDED AS EXPECTED WITH NO REPORTED INTRAOPERATIVE COMPLICATIONS. FINAL INSPECTION CONFIRMED APPROPRIATE FIT AND STABILITY OF THE COMPONENTS, WITH NO EVIDENCE OF MALALIGNMENT OR IMPROPER FIXATION. THE PATIENT TOLERATED THE PROCEDURE, WAS AWAKENED FROM ANESTHESIA, AND TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 22993250 ↗
• InjuryJun 18, 2025Loosening 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 COMPONENT OF COLUMBUS KNEE SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THIS KNEE IMPLANT WAS "DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT". THERE WAS POSTOPERATIVE MECHANICAL LOOSENING. IT WAS NOTED THAT THE SURGEON EASILY REMOVED THE IMPLANT BY HAND DURING THE REVISION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 22285670 ↗
• InjuryJun 13, 2025Loosening 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 COMPONENT OF COLUMBUS KNEE SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THIS KNEE IMPLANT WAS "DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT". THERE WAS POSTOPERATIVE MECHANICAL LOOSENING. IT WAS NOTED THAT THE SURGEON EASILY REMOVED THE IMPLANT BY HAND DURING THE REVISION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 22206490 ↗
• InjuryJun 13, 2025Loosening 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 COMPONENT OF COLUMBUS KNEE SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THIS KNEE IMPLANT WAS "DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT". THERE WAS POSTOPERATIVE MECHANICAL LOOSENING. IT WAS NOTED THAT THE SURGEON EASILY REMOVED THE IMPLANT BY HAND DURING THE REVISION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 22205340 ↗
• 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 XC (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.

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

  MAUDE report 11012825 ↗