VEGA System® PS NX130Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046963810887), received between Oct 8, 2020 and Mar 19, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ISSUES FOLLOWING A LEFT KNEE PROSTHESIS THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED JULY 26, 2021, THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY FOR TRICOMPARTMENTAL DEGENERATIVE JOINT DISEASE (DJD) WITH MARKED TIBIAL TORSION. THE PROCEDURE WAS PERFORMED USING AESCULAP COMPONENTS, WHICH WERE CEMENTED IN PLACE USING PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THAT THE COMPONENTS WERE IMPLANTED WITH APPROPRIATE ALIGNMENT AND STABILITY, AND THE PATIENT WAS TAKEN TO RECOVERY IN GOOD CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED (B)(6) 2023, THE PATIENT UNDERWENT LEFT KNEE MANIPULATION UNDER ANESTHESIA DUE TO POSTOPERATIVE ADHESIVE CAPSULITIS. THE PROCEDURE INVOLVED MANIPULATION OF THE KNEE FROM FULL EXTENSION TO APPROXIMATELY 125 DEGREES OF FLEXION. NO AUDIBLE OR PALPABLE ABNORMALITIES WERE NOTED, AND NO STRUCTURAL CHANGES TO THE KNEE WERE IDENTIFIED DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO RECOVERY IN GOOD CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 24639441 ↗
• InjuryMay 12, 2021Migration; Migration

  INVOLVED COMPONENTS. NX043 - PATELLA 3-PEGS P3 - 52469178. NN261Z - AS TIBIAL OBTURATOR D12MM - 52595742. NX055Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T3 - 52584296. NX032Z - AS VEGA PS FEMORAL COMP.CEMENTED F5R - 52277676. AE-QAS-COMPET-IMP - COLLECT.NO.QAS IMPLANTS FROM COMPETITORS - UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11813933 ↗
• InjuryMay 12, 2021Migration; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NX130 - VEGA PS GLIDING SURFACE T3/3+ 10MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THIS PATIENT PRESENTED TO ORTHOPAEDIC CLINIC 8 MONTHS POST OP REPORTING THAT SHE HEARD A POP IN HER KNEE WHILE AMBULATORY. X RAY FOUND THAT THE VEGA POLYETHYLENE INSERT SET SCREW HAD BACKED OUT COMPLETELY AND WAS FREE FLOATING IN THE KNEE JOINT. SURGERY WAS SCHEDULED. SURGEON RETRIEVED THE SCREW , FULLY INTACT, AND REMOVED IT ALONG WITH THE POLYETHYLENE COMPONENT. A NEW POLYETHYLENE INSERT WAS IMPLANTED AND A NEW SET SCREW WAS FULLY SEATED IN THE POLYETHYLENE INSERT. THE PATIENT LEFT THE OPERATING ROOM WITH A FULLY FUNCTIONING KNEE REPLACEMENT. THE SURGEON USED PALACOS G CEMENT DURING THE INITIAL SURGERY WHICH WAS (B)(6) 2020. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS ITEM CODE - DESCRIPTION - BATCH: NX043 - PATELLA 3-PEGS P3 - 52469178; NN261Z - AS TIBIAL OBTURATOR D12MM - 52595742; NX055Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T3 - 52584296; NX032Z - AS VEGA PS FEMORAL COMP.CEMENTED F5R - 52277676; AE-QAS-COMPET-IMP

  Patient problems: Failure of Implant

  MAUDE report 11813858 ↗
• InjuryMar 4, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2013 (LEFT) (B)(6) 2013 (RIGHT). ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A LEFT KNEE REVISION SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2015 LEFT KNEE. 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: NX013Z (PS FEMUR CEMENTED F6N LT), NX055Z (PS TIBIA CEMENTED T3), NN260P (PEEK PLUG F/ TIBIA), NX044 (UNIVERSAL PATELLA P4), NX130 (PS PE INSERT T3/T3+, 10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00355, 2916714-2020-00356, 2916714-2020-00357, 2916714-2020-00358.

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

  MAUDE report 11416209 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 DIFFICULTY WALKING. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015 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: NX011Z(PS FEMUR CEMENTED F5N LT), NX043 (UNIVERSAL PATELLA P3), NX055Z (PS TIBIA CEMENTED T3), NX130 (PS PE INSERT T3/T3+, 10MM), NN261Z(TIBIAL OBTURATOR D12MM, L7MM). THE CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00249, 2916714-2020-00250, 2916714-2020-00251, 2916714-2020-00253.

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

  MAUDE report 11014971 ↗
• InjuryDec 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. THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN RIGHT KNEE, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2012, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH HAD RESULTED IN A REVISION SURGERY. 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). NX044 (UNIVERSAL PATELLA P4). NX055Z (PS TIBIA CEMENTED T3). NX130 (PS PE INSERT T3/T3+, 10MM). NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS NOT SPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00631. 2916714-2020-00632. 2916714-2020-00633. 2916714-2020-00635.

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

  MAUDE report 10969814 ↗
• InjuryNov 10, 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 PS FEMUR F5N R (PART #NX031Z) (REF. ASSOCIATED MDR ID 2916714-2020-00521), VEGA SYSTEM PATELLA 3-PEG SIZE P3 (PART # NX043) (REF. ASSOCIATED MDR ID 2916714-2020-00522), VEGA SYSTEM PS TIBIA PLATEAU T3, CEMENTED IMPLANT (PART # NX055Z) (REF. ASSOCIATED MDR ID 2916714-2020-00523), PS+ GLIDING SURFACE IMPLANT 10MM T3/T3+ (PART # NX130), AND A VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P) (REF. ASSOCIATED MDR ID 2916714-2020-00525), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND SWELLING IN RIGHT KNEE, WHICH RESTRICTED ROUTINE DAILY ACTIVITIES. A SUBSEQUENT X-RAY SHOWED POSSIBLE LOOSENING OF THE TIBIAL COMPONENT AND A RADIOLUCENT LINE AROUND THE TIBIAL COMPONENT. BONE SCANS SHOWED AN INCREASED UPTAKE IN THE TIBIAL COMPONENT. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE A WELL-FIXED PATELLAR COMPONENT AND LOSING OF THE TIBIAL AND FEMORAL COMPONENTS. THE CEMENT USED DURING THE PRIMARY SURGERY WAS IDENTIFIED AS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. TH

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10815760 ↗
• 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) 2016, 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). INVOLVED COMPONENTS: NX042 (UNIVERSAL PATELLA P2); NX033Z(PS FEMUR CEMENTED F6N RT); NN264Z(TIBIAL OBTURATOR D14MM, L7MM); NX056Z(PS TIBIA CEMENTED T3+); NX130 (PS PE INSERT T3/T3+, 10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00476; 2916714-2020-00477; 2916714-2020-00478; 2916714-2020-00479.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10653405 ↗