VEGA System® PS NX121Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046963810832), received between Dec 22, 2020 and Feb 19, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA PS GLIDING SURFACE T2/2+ 12MM (PART # NX121) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINT THERE WAS A POSTOPERATIVE LOOSENING OF THE IMPLANT AT THE FEMORAL COMPONANT. X RAYS SHOW THAT THE CEMENT DID NOT ADHERE TO THE IMPLANTS OR THE BONE. REPORTEDLY THE PAITENT COMPLAINED OF RIGHT KNEE PAIN AFTER THE INITIAL PROCEDURE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 7 2024 WITH THE ITEM AN LOT INFORMATION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4) (B)(4) (2916714-2023-00092) NN261Z. (B)(4) (2916714-2023-00093) NX029Z. (B)(4) (2916714-2023-00094) NX042. (B)(4) (2916714-2024-00006) NX053Z.

  Patient problems: Failure of Implant

  MAUDE report 18735607 ↗
• InjuryMar 8, 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) 2014. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND DIFFICULTY IN WALKING OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION SURGERY OCCURRED ON (B)(6) 2015. 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: NN260P (PEEK PLUG F/ TIBIA). NX053Z (PS TIBIA CEMENTED T2). NX042 (UNIVERSAL PATELLA P2). NX031Z (PS FEMUR CEMENTED F5N RT). NX121 (PS PE INSERT T2/T2+, 12MM). THE CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00319, 2916714-2020-00320, 2916714-2020-00321, 2916714-2020-00322.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 11440321 ↗
• InjuryMar 8, 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 VEGA KNEE IMPLANT(S). IT WAS REPORTED ON (B)(6) 2018 .THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PATIENT EXPERIENCED PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING OF THE IMPLANT WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2015. 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). INVOLVED COMPONENTS: NX053Z (AS VEGA PS TIBIAL PLATEAU), NX031Z (PS FEMUR CEMENTED F5N RT), NX121 (PS PE INSERT T2/T2+, 12MM), NN260P (PEEK PLUG F/ TIBIA), NX043 (UNIVERSAL PATELLA P3), THE CEMENT USED WAS UNKNOWN. ASSOCIATED MEDWATCHES: 2916714-2020-00324, 2916714-2020-00325, 2916714-2020-00327, 2916714-2020-00328.

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

  MAUDE report 11436228 ↗
• InjuryJan 5, 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 THE RIGHT KNEE AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY 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)2018. 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), NX043 (UNIVERSAL PATELLA P3), NX053Z (PS TIBIA CEMENTED T2), NX121(PS PE INSERT T2/T2+, 12MM), NN260P(PEEK PLUG F/TIBIA). CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. ASSOCIATED MEDWATCHES: 2916714-2020-00639, 2916714-2020-00640, 2916714-2020-00641, 2916714-2020-00642, 2916714-2020-00643.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11118348 ↗
• InjuryDec 22, 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 PAIN, SWELLING IN LEFT KNEE AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY TO LEFT 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. 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: NX013Z(PS FEMUR CEMENTED F6N LT). NX043 (UNIVERSAL PATELLA P3). NX053Z (PS TIBIA CEMENTED T2). NX121 (PS PE INSERT T2/T2+, 12MM). NN260P(PEEK PLUG F/ TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00650 2916714-2020-00651 2916714-2020-00652 2916714-2020-00654.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11058475 ↗