AS VEGA System® PS NX056ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046963810474), received between Oct 8, 2020 and Dec 4, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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.

• InjuryDec 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT THERE WAS AN ISSUE WITH THE AESCULAP CERAMIC-COATED KNEE IMPLANT. REPORTEDLY THE KNEE IMPLANT WAS DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT. THE INDEX SURGERY WAS PERFORMED SOMETIME IN (B)(6) 2018. REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 23720349 ↗
• 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 22205722 ↗
• InjuryMar 5, 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 NX056Z AS VEGA PS TIBIAL PLATEAU CEMENTED T3 IT WAS REPORTED ON (B)(6) 2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT. AFTER FIRST REVISION SURGERY, PATIENT CONTINUED TO EXPERIENCE PAIN, SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A SECOND REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015. WITH FIRST REVISION IN (B)(6) 2015, WITH ANOTHER VEGA IMPLANT. THE SECOND REVISION SURGERY OCCURRED ON (B)(6) 2017, WITH AN UNIDENTIFIED NON AESCULAP IMPLANT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS. NX030Z PS FEMUR CEMENTED F4 RT NN264Z TIBIAL OBTURATOR D14MM, L7MM NX043 UNIVERSAL PATELLA P3 NX132 PS PE INSERT T3, 14MM THE COMPONENTS LISTED ARE RELATED TO THE PRIMARY SURGERY. IT IS UNKNOWN EXACTLY WHICH COMPONENTS WERE REPLACED IN THE FIRST AND SECOND REVISION SURGERY.

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

  MAUDE report 11424132 ↗
• InjuryMar 5, 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 KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT. AFTER FIRST REVISION SURGERY, PATIENT CONTINUED TO EXPERIENCE PAIN, SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A SECOND REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015 WITH FIRST REVISION IN (B)(6) 2015, WITH ANOTHER VEGA IMPLANT. THE SECOND REVISION SURGERY OCCURRED ON (B)(6) 2017, WITH AN UNIDENTIFIED NON-AESCULAP IMPLANT.. 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: NX030Z (PS FEMUR CEMENTED F4 RT), NN264Z (TIBIAL OBTURATOR D14MM, L7MM), NX043 (UNIVERSAL PATELLA P3), NX056Z (PS TIBIA CEMENTED T3+), NX132 (PS PE INSERT T3/T3+, 14MM). THE COMPONENTS LISTED ARE RELATED TO THE PRIMARY SURGERY. IT IS UNKNOWN EXACTLY WHICH COMPONENTS WERE REPLACED IN THE FIRST AND SECOND REVISION

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

  MAUDE report 11424024 ↗
• InjuryOct 8, 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, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2016 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2017. 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: NX042 (UNIVERSAL PATELLA P2), NX033Z(PS FEMUR CEMENTED F6N RT), NN264Z(TIBIAL OBTURATOR D14MM, L7MM), NX056Z(PS TIBIA CEMENTED T3+), NX130 (PS PE INSERT T3/T3+, 10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00476, 2916714-2020-00477, 2916714-2020-00478, 2916714-2020-00480.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10653374 ↗