VEGA System® PS NX051KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963810368), received between Mar 24, 2021 and Jun 8, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00449 ((B)(4) + NX051K) AND 9610612-2021-00450 ((B)(4) + NX009K). INVOLVED COMPONENTS: NX110 - VEGA PS GLIDING SURFACE T1/1+ 10MM - 52206779.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 11959128 ↗
• InjuryMar 24, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA PS GLIDING SURFACE T1/1+ 10MM (PART # NX110) AND A VEGA PS TIBIAL PLATEAU CEMENTED T1 (PART # NX051) WERE USED DURING A TOTAL KNEE REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PATIENT FELT DISCOMFORT IN KNEES ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT RECEIVED AN X-RAY AND FOUND THAT THE INSERT FIXING SCREW HAD COME OFF. REPORTEDLY, THE SCREW HAD BEEN FLOATING SINCE (B)(6) OF 2020, BUT THE PHYSICIAN WAS NOT AWARE AT THAT TIME. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED THAT THERE WAS NO DAMAGE FOUND ON THE REMOVED INSERTS AND SCREWS. IT HAS BEEN CONFIRMED THAT THE SCRATCHES ON THE FRONT OF THE INSERT ARE THOSE AT THE TIME OF REMOVAL AND ARE NOT SCRATCHED OR DAMAGED BEFORE REMOVAL. NO PATIENT ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAD NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00196 (400504528 + NX110). 9610612-202

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 11564157 ↗