VEGA System® PS NX140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963810948), received between Sep 29, 2020 and May 2, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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.

• InjuryMay 2, 2024Fracture; Fracture

  UPDATE: THE COMPLAINED PRODUCT WAS NX140 - VEGA PS GLIDING SURFACE T4/4+ 10MM. THERE WAS A POLYETHYLENE FRACTURE POSTOPERATIVELY ON THE LEFT TOTAL KNEE; POSITIVE "POSTERIOR DRAWER". ASSOCIATED USER MEDWATCH REPORT: MW5153839. MANUFACTURING SITE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THE AVAILABLE LOT NUMBER; THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF PRODUCTION. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 19228522 ↗
• 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 A VEGA KNEE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN AND INSTABILITY. THE PATIENT CLAIMED TO HAVE BEEN ABLE TO HEAR "RATTLING" SOUNDS POSTOPERATIVELY; RESULTS OF X-RAYS SHOWED LOOSENING OF THE IMPLANT. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2015, AND THE REVISION WAS PERFORMED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS WERE LOOSENING OF THE TIBIAL KEEL AND FEMORAL COMPONENT. SURGICAL CEMENT CONTINUED TO ADHERE TO THE BONE BUT HAD NOT ADHERED TO THE IMPLANT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NN484 (COLUMBUS PRI/REV PE PATELLA 3-PEGS P4). NX058Z (PS TIBIA CEMENTED T4+). NX140 (PS PE INSERT T4/T4+, 10MM). NN264Z (TIBIAL OBTURATOR D14MM, L7MM). NX034Z (PS FEMUR CEMENTED F6 RT). THE CEMENT USED WAS NOT SPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00583. 2916714-2020-00584. 2916714-2020-00586. 2916714-2020-00587.

  Patient problems: Pain

  MAUDE report 10813461 ↗
• InjurySep 29, 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, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2014 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2017. 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). ASSOCIATED MEDWATCHES: 2916714-2020-00378, 2916714-2020-00379, 2916714-2020-00380, 2916714-2020-00382. INVOLVED COMPONENTS: NX033Z (PS FEMUR CEMENTED F6N RT) NX057Z (PS TIBIA CEMENTED T4) NN264Z (TIBIAL OBTURATOR D14MM, L7MM) NX140 (PS PE INSERT T4/T4+, 10MM) NX043 (UNIVERSAL PATELLA P3) CEMENT: ZIMMER PALACOS R+G RADIOPAQUE BONE CEMENT(00-1113-140-01)

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10601306 ↗