VEGA System® PS NX102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963810726), received between Nov 9, 2020 and Feb 25, 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 16, 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.

• InjuryFeb 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  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 AND DIFFICULTY WALKING OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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: NX007Z (PS FEMUR CEMENTED F3N LT); NN260P (PEEK PLUG F/ TIBIA); NX049Z (PS TIBIA CEMENTED T0); NX042 (UNIVERSAL PATELLA P2); NX102 (PS PE INSERT T0/T0+, 14MM) CEMENT USED IS UNKNOWN. ASSOCIATED MEDWATCHES: 2916714-2020-00312, 2916714-2020-00313, 2916714-2020-00314, 2916714-2020-00315.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11381974 ↗
• InjuryNov 9, 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 AS VEGA KNEE, RIGHT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN AND SWELLING; AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2012, AND THE REVISION WAS PERFORMED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS WERE REACTIVE SYNOVITIS WITH AREAS OF NECROTIC TISSUE AND LOOSENING OF THE FEMORAL COMPONENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX027Z (PS FEMUR CEMENTED F3N RT). NX042 (UNIVERSAL PATELLA P2). NX049Z (PS TIBIA CEMENTED T0). NX102 (PS PE INSERT T0/T0+, 14MM). NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS BIOMET COBALT HV BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00605. 2916714-2020-00606. 2916714-2020-00607. 2916714-2020-00609.

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

  MAUDE report 10809197 ↗