VEGA System® PS NX120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046963810825), received between Oct 6, 2020 and Jan 21, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 18, 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.

• InjuryJan 21, 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 KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SWELLING IN RIGHT KNEE AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY TO RIGHT KNEE WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2016. THE CEMENT USED DURING PROCEDURE IS UNAVAILABLE. 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: NX033Z(PS FEMUR CEMENTED F6N RT), NX043 (UNIVERSAL PATELLA P3), NX053Z (PS TIBIA CEMENTED T2), NX120 (PS PE INSERT T2/T2+, 10MM), NN260P(PEEK PLUG F/ TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00655, 2916714-2020-00656, 2916714-2020-00657, 2916714-2020-00658, 2916714-2020-00659.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11210670 ↗
• InjuryJan 4, 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 KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN, NUMBNESS AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2014 AND THERE WAS NO REPORTED REVISION SURGERY. 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: NX031Z(PS FEMUR CEMENTED F5N RT), NN261Z(TIBIAL OBTURATOR D12MM, L7MM), NX053Z (PS TIBIA CEMENTED T2), NX043 (UNIVERSAL PATELLA P3), NX120(PS PE INSERT T2/T2+, 10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00660, 2916714-2020-00661, 2916714-2020-00662, 2916714-2020-00663.

  Patient problems: Joint Laxity; Numbness; Pain

  MAUDE report 11113574 ↗
• InjuryNov 10, 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. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN BOTH KNEES; NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2012, AND THE REVISION WAS PERFORMED ON (B)(6) 2016. INTRAOPERATIVE FINDINGS WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX031Z (PS FEMUR CEMENTED F5N RT). NX043 (UNIVERSAL PATELLA P3). NX054Z (PS TIBIA CEMENTED T2+). NX120 (PS PE INSERT T2/T2+, 10MM). NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS NOT SPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00495. 2916714-2020-00496. 2916714-2020-00497. 2916714-2020-00499.

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

  MAUDE report 10816401 ↗
• 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) 2013 AND THERE WAS NO REPORTED REVISION SURGERY. 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: NX054Z (PS TIBIA CEMENTED T2+), NX044 (UNIVERSAL PATELLA P4), NX120 (PS PE INSERT T2/T2+, 10MM), NX011Z(PS FEMUR CEMENTED F5N LT), NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00460, 2916714-2020-00461, 2916714-2020-00463, 2916714-2020-00464.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10652688 ↗
• InjuryOct 6, 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. 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) 2012 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 / MALFUNCTION IS FILED UNDER REFERENCE XC 100026196. ASSOCIATED MEDWATCHES: 2916714-2020-00406 2916714-2020-00407 2916714-2020-00408 2916714-2020-00409 INVOLVED COMPONENTS: NX011Z (PS FEMUR CEMENTED F5N LT) NN260P (PEEK PLUG F/ TIBIA) NX053Z (PS TIBIA CEMENTED T2) NX044 (UNIVERSAL PATELLA P4) NX120 (PS PE INSERT T2/T2+, 10MM) THE CEMENT USED IS UNIDENTIFIED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10635823 ↗