AS VEGA System® PS NX028ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963810108), received between Apr 13, 2021 and Apr 19, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 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 A VEGA PS FEMORAL COMPONENT. AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, DIFFICULTY WALKING, SWELLING, AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2016. A REVISION WAS REQUIRED. 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 XC REFERENCE (B)(4). CEMENT USED: UNIDENTIFIED

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

  MAUDE report 11686016 ↗
• InjuryApr 19, 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 NX028Z - AS VEGA PS FEMORAL COMP.CEMENTED F3R. IT WAS REPORTED ON 12APR2019, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, DIFFICULTY WALKING, SWELLING, AND LOOSENING AND INSTABILITY OF THE IMPLANT, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2016. 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). CEMENT USED: UNIDENTIFIED.

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

  MAUDE report 11685986 ↗
• InjuryApr 13, 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 AN AS VEGA PS FEMORAL COMP CEMENTED. THE ORIGINAL TOTAL KNEE ARTHROPLASTY (TKA) AND IMPLANTATION OCCURRED ON (B)(6) 2018. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE LOOSENED POSTOPERATIVELY. UPON REMOVAL, THE FEMORAL IMPLANT EXHIBITED VERY LITTLE CEMENT BONDING. A REVISION SURGERY WAS NECESSARY ON (B)(6) 2021. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX110 - VEGA PS GLIDING SURFACE T1/1+ 10MM - LOT 52396660. NX051Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T1 - LOT 52424675. NN261Z - AS TIBIAL OBTURATOR D12MM - LOT 52413272. ORIGINAL CEMENT: STRYKER SIMPLEX..

  Patient problems: Failure of Implant

  MAUDE report 11657013 ↗