VEGA System® PS NX131Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046963810894), received between Nov 6, 2020 and Jul 16, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA PS GLIDING SURFACE T3/3+ 12MM (PART # NX131) WAS IMPLANTED ON (B)(6) 2019. ACCORDING TO THE COMPLAINT DESCRIPTION, THIS KNEE IMPLANT WAS "DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT". THERE WAS POSTOPERATIVE MECHANICAL LOOSENING. IT WAS NOTED THAT THE SURGEON EASILY REMOVED THE IMPLANT BY HAND DURING THE REVISION. THE PATIENT WAS REVISED TO A PRODUCT FROM A DIFFERENT MANUFACTURER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 22518924 ↗
• InjuryJan 19, 2023Loosening 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 T3/3+ 12MM (ITEM NX131) WAS IMPLANTED DURING A LEFT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ASEPTIC LOOSENING OF AESCULAP VEGA CEMENTED TOTAL KNEE REPLACEMENT WITH-DE-BONDING OF THE IMPLANT FROM THE CEMENT MANTLE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE XC 100032170 CC 400582828. ASSOCIATE MEDWATCH REPORTS: 400582824_2916714-2023-00006_MDR, 400582825_2916714-2023-00007_MDR, 400582826_2916714-2023-00008_MDR, 400582827_2916714-2023-00009_MDR.

  Patient problems: Failure of Implant

  MAUDE report 16206242 ↗
• 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 AS VEGA KNEE, LEFT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING; AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION OCCURRED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS WHICH RESULTED IN THE REVISION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX013Z (PS FEMUR CEMENTED F6N LT), NX043 (UNIVERSAL PATELLA P3), NX055Z (PS TIBIA CEMENTED T3), NX131 (PS PE INSERT T3/T3+, 12MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00531, 2916714-2020-00532, 2916714-2020-00533, 2916714-2020-00534, 2916714-2020-00535.

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

  MAUDE report 11117891 ↗
• InjuryNov 11, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA KNEE IMPLANT SYSTEM, COMPRISED OF THE FOLLOWING COMPONENTS, VEGA SYSTEM TIBIA OBTURATOR (PART # NN264Z) (REF. ASSOCIATED MDR ID 2916714-2020-00589), COLUMBUS PATELLA SIZE P4 (PART # NN484) (REF. ASSOCIATED MDR ID 2916714-2020-00590), VEGA SYSTEM PS FEMUR F6N R (PART #NX033Z) (REF. ASSOCIATED MDR ID 2916714-2020-00591), VEGA SYSTEM PS TIBIA PLATEAU T3+, CEMENTED IMPLANT (PART # NX056Z) (REF. ASSOCIATED MDR ID 2916714-2020-00592), AND A VEGA SYSTEM PS GLIDING SURFACE IMPLANT 12MM T3/T3+ (PART # NX131), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED KNEE PAIN (MOSTLY LOCATED ON THE INSIDE OF THE KNEE JOINT), WEAKNESS IN RIGHT KNEE, AND DIFFICULTY WITH CLIMBING STAIRS AND RISING FROM A SEATED POSITION. A SUBSEQUENT X-RAY SHOWED LOOSENING OF THE TIBIAL IMPLANT, WHICH RESULTED IN A REVISION SURGERY PERFORMED ON (B)(6) 2017. POST-REPLACEMENT SURGERY FINDINGS SHOWED LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS. THE CEMENT USED DURING THE PRIMARY SURGERY IS UNKNOWN. NO KNOWN ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE REVISION SURGERY

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10823643 ↗
• 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 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. CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. 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), NX055Z (PS TIBIA CEMENTED T3), NX131(PS PE INSERT T3/T3+,12MM), NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00555, 2916714-2020-00556, 2916714-2020-00557, 2916714-2020-00559.

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

  MAUDE report 10809797 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA KNEE IMPLANT SYSTEM, COMPRISED OF THE FOLLOWING COMPONENTS, VEGA SYSTEM PS TIBIA PLATEAU T3, CEMENTED IMPLANT (PART # NX055Z) (REF. ASSOCIATED MDR ID 2916714-2020-00526), VEGA SYSTEM PS FEMUR F6N L (PART #NX013Z) (REF. ASSOCIATED MDR ID 2916714-2020-00527), VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P) (REF. ASSOCIATED MDR ID 2916714-2020-00528), PS+ GLIDING SURFACE IMPLANT 12MM T3/T3+ (PART # NX131), AND A PATELLA 3-PEG P2 (PART # NX044) (REF. ASSOCIATED MDR ID 2916714-2020-00530), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED KNEE PAIN, SWELLING, AND DIFFICULTY WALKING. THERE WAS NO REPORTED REVISION SURGERY. THE CEMENT USED DURING THE PRIMARY SURGERY IS UNKNOWN. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX055Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T3 - LOT # 51904336, NX013Z - AS VEGA PS FEMORAL COMP.CEMENTED F6N L - LOT # 51

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10804437 ↗