AS VEGA System® PS NX049ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046963810337), received between Sep 29, 2020 and Aug 14, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Patient-Device Incompatibility

  An outside law firm reported that a patient experienced postoperative loosening following a left total knee arthroplasty. According to the available medical records, the patient underwent a left total knee arthroplasty on (b)(6) 2021. On (b)(6) 2024, the patient underwent revision of the left patellar component for aseptic loosening. The operative report documented that the femoral and tibial components were inspected and appeared to have no loosening. The patellar button was evaluated, and when an osteotome was placed at the medial side of the button, the button reportedly popped out. The remaining cement was removed from the patella and the patella was resurfaced to allow for improved tracking. No intraoperative complications were reported, and the patient was taken to recovery in stable condition. Subsequent records documented further concerns involving the left total knee prosthesis. At a (b)(6) 2025 postoperative evaluation, radiographs demonstrated a posterior-stabilized total knee replacement with the patella resurfaced. The femoral component appeared loose, with severe periprosthetic osteolysis about the femur. The patient was assessed with mechanical loosening and peripros

  Patient problems: Insufficient Information

  MAUDE report 50260357 ↗
• InjuryApr 27, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES FOLLOWING A LEFT KNEE PROSTHESIS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 FOR DEGENERATIVE JOINT DISEASE. THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POSTOPERATIVELY, THE PATIENT INITIALLY REPORTED IMPROVEMENT, WITH FOLLOW-UP ON (B)(6) 2021 NOTING THAT THE PATIENT WAS DOING WELL WITH NO PAIN OR COMPLAINTS. HOWEVER, BY(B)(6) 2022, THE PATIENT REPORTED A FALL WITH SUBSEQUENT LEFT KNEE PAIN, DECREASED RANGE OF MOTION, AND LIGAMENTOUS INSTABILITY. IMAGING AND CLINICAL FINDINGS AT THAT TIME NOTED DEGENERATIVE CHANGES AND LAXITY. THE PATIENT CONTINUED TO REPORT PERSISTENT KNEE SYMPTOMS DESPITE CONSERVATIVE MANAGEMENT, INCLUDING INJECTIONS. BY (B)(6) 2022, THE PATIENT REPORTED ONGOING KNEE PAIN, THOUGH IMAGING DID NOT DEMONSTRATE LOOSENING AT THAT TIME. AT FOLLOW-UP ON (B)(6), 2026, IMAGING DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH FINDINGS OF MECHANICAL LOOSENING OF THE FEMORAL COMPONENT, ASSOCIATED LUCENCY, AND INSTABILITY. CLINICAL EXAMINATION CONFIRMED LIGAMENTOUS LAXITY, EFFUSION, AND PAIN. DIAGNOSES INCLUDED MECHANI

  Patient problems: Failure of Implant

  MAUDE report 24999163 ↗
• InjuryFeb 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NX049Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T0. IT WAS REPORTED ON (B)(6) 2018 THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND DIFFICULTY WALKING WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015 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 IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX007Z (PS FEMUR CEMENTED F3N LT); NN260P (PEEK PLUG F/ TIBIA); NX042 (UNIVERSAL PATELLA P2); NX102 (PS PE INSERT T0/T0+, 14MM). CEMENT USED IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 11382078 ↗
• 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 APRIL 21, 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, (B)(4), 2916714-2020-00315, 2916714-2020-00316.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11381707 ↗
• InjuryJan 13, 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 NX049Z-AS VEGA PS TIBIAL PLATEAU CEMENTED T0. IT WAS REPORTED ON (B)(6) 2019, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN LEFT KNEE, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE A WELL-FIXED PATELLAR COMPONENT AND 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. CEMENT USED WAS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. INVOLVED COMPONENTS: NX042 (UNIVERSAL PATELLA P2), NX103 (PS PE INSERT T0/T0+, 16MM), NN260P (PEEK PLUG F/ TIBIA). THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORT: 9610612-2020-00556 (NX009Z 400485778), 9610612-2020-00557 (NX049Z 400485780).

  Patient problems: Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 11164916 ↗
• 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, 2916714-2020-00608, 2916714-2020-00609.

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

  MAUDE report 10809201 ↗
• InjuryNov 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 VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN LEFT KNEE AND NORMAL DAILY ACTIVITIES WAS RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE A WELL-FIXED PATELLAR COMPONENT AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH RESULTED IN REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURED 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: NX009Z (PS FEMUR CEMENTED F4N LT). NX042 (UNIVERSAL PATELLA P2). NX049Z (PS TIBIA CEMENTED T0). NX103(PS PE INSERT T0/T0+,16MM). NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00500, 2916714-2020-00501, 2916714-2020-00503, 2916714-2020-00504.

  Patient problems: Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 10804615 ↗
• InjuryNov 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, LEFT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT 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) 2013, AND THE REVISION WAS PERFORMED ON (B)(6) 2016. INTRAOPERATIVE FINDINGS SHOWED LOOSENING OF THE FEMORAL COMPONENT, METALLOSIS AND DEBRIS IN THE KNEE JOINT, AND REACTIVE SYNOVITIS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT), NX042 (UNIVERSAL PATELLA P2), NX049Z (PS TIBIA CEMENTED T0), NX100 (PS PE INSERT T0/T0+, 10MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS UNSPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00506, 2916714-2020-00507, 2916714-2020-00509, 2916714-2020-00510.

  Patient problems: Ambulation or Postural Difficulties; Pain; Synovitis

  MAUDE report 10802524 ↗
• InjuryNov 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. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE DEVICE. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2015, AND THE REVISION WAS PERFORMED ON (B)(6) 2018. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NN261Z (TIBIAL OBTURATOR D12MM, L7MM); NX049Z (PS TIBIA CEMENTED T0); NX008Z (PS FEMUR CEMENTED F3 LT); NX042 (UNIVERSAL PATELLA P2); NX101 (PS PE INSERT T0/T0+, 12MM). THE CEMENT USED WAS UNSPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00490; 2916714-2020-00492; 2916714-2020-00493; 2916714-2020-00494.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 10801740 ↗
• 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, SWELLING, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015 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). ASSOCIATED MEDWATCHES: 2916714-2020-00411, 2916714-2020-00412, 2916714-2020-00414, 2916714-2020-00415. INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT). NX100 (PS PE INSERT T0/T0+, 10MM). NX049Z (PS TIBIA CEMENTED T0). NN260P (PEEK PLUG F/ TIBIA). NX042 (UNIVERSAL PATELLA P2). THE CEMENT USED IS UNIDENTIFIED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10601799 ↗