VEGA System® PS NX132Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963810900), received between Mar 5, 2021 and Jan 19, 2023 — 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.

• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INVESTIGATION COMPLETE.

  Patient problems: Failure of Implant

  MAUDE report 16207522 ↗
• InjuryApr 1, 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 KNEE IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DIFFICULTY WALKING, AND LOOSENING OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. A REVISION SURGERY WAS NECESSARY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE REPORT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT IS FILED UNDER XC REFERENCE (B)(4). INVOLVED COMPONENTS: NX132 - VEGA PS GLIDING SURFACE T3/3+ 14MM - LOT 51949663, NN260P - PLUG F/TIBIAL PLATEAU - LOT 51974495, NX013Z - AS VEGA PS FEMORAL COMP. CEMENTED F6N L - LOT 51927043, NX055Z (PS TIBIA CEMENTED T3); - LOT 51938561, NX044 - PATELLA 3-PEGS P4 - LOT 51911583, CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00308, 2916714-2020-00309, 2916714-2020-00310, 2916714-2020-00311.

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

  MAUDE report 11604188 ↗
• 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 11424133 ↗