VEGA System® PS NX112Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046963810788), received between Nov 6, 2020 and Jan 20, 2023 — classified as 6 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 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.

• InjuryJan 20, 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 T1/1+ 14MM (PART# NX112) WAS IMPLANTED DURING A LEFT TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS WAS OBSERVED. THE PATELLA WAS NOTED AS BEING IN GOOD POSITION WITH NO EVIDENCE OF LOOSENING. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. 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 PROCEDURE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).. ASSOCIATED REPORTS: 400582830_2916714-2023-00011_MDR, 400582831_2916714-2023-00012_MDR, 400582832_2916714-2023-00013_MDR, 400582833_2916714-2023-00014_MDR.

  Patient problems: Failure of Implant

  MAUDE report 16216571 ↗
• InjuryJan 28, 2021Loosening 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 2916714-2020-00624), VEGA SYSTEM PATELLA 3-PEG SIZE P3 (PART # NX043) (REF. ASSOCIATED MDR ID 2916714-2020-00625), VEGA SYSTEM PS TIBIA PLATEAU T1, CEMENTED IMPLANT (PART # NX051Z) (REF. ASSOCIATED MDR ID 2916714-2020-00626), VEGA SYSTEM PS GLIDING SURFACE IMPLANT 14MM T1/T1+ (PART # NX112), AND A VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P) (REF. ASSOCIATED MDR ID 2916714-2020-00628), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND SWELLING IN IN THE RIGHT KNEE, WHICH RESTRICTED ROUTINE DAILY ACTIVITIES. THE PATIENT UNDERWENT A REVISION SURGERY PERFORMED ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S IMPLANT. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY REVEALED LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS. NO COMPONENTS WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO KNOWN ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE REVISION SURGERY. ADDI

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 11248039 ↗
• 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 LEFT 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: NX009Z (PS FEMUR CEMENTED F4N LT), NX042 (UNIVERSAL PATELLA P2), NX051Z (PS TIBIA CEMENTED T1), NX112 (PS PE INSERT T1/T1+, 14MM), NN260P (PEEK PLUG F/ TIBIA). CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. ASSOCIATED MEDWATCHES: 2916714-2020-00619, 2916714-2020-00620, 2916714-2020-00621, 2916714-2020-00623.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11120437 ↗
• 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 PS FEMUR F5N R (PART #NX031Z) (REF. ASSOCIATED MDR ID 2916714-2020-00550), VEGA SYSTEM PATELLA 3-PEG SIZE P2 (PART # NX042) (REF. ASSOCIATED MDR ID 2916714-2020-00551), VEGA SYSTEM PS TIBIA PLATEAU T1, CEMENTED IMPLANT (PART # NX051Z) (REF. ASSOCIATED MDR ID 2916714-2020-00552), VEGA SYSTEM PS GLIDING SURFACE IMPLANT 14MM T1/T1+ (PART # NX112), AND A VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P) (REF. ASSOCIATED MDR ID 2916714-2020-00554), 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 BOTH KNEES, WHICH RESTRICTED ROUTINE DAILY ACTIVITIES. THE PATIENT UNDERWENT A REVISION SURGERY PERFORMED ON (B)(6) 2016. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY REVEALED 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. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFOR

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10826169 ↗
• 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 A VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN AND SWELLING IN RIGHT KNEE AND NORMAL DAILY ACTIVITIES WAS RESTRICTED DUE TO PAIN. A SUBSEQUENT X-RAY SHOWED POSSIBLE LOOSENING OF THE TIBIAL COMPONENT AND A RADIOLUCENT LINE AROUND THE TIBIAL COMPONENT. DURING REPLACEMENT SURGERY INTRAOPERATIVE FINDINGS WERE 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: NX031Z (PS FEMUR CEMENTED F5N RT), NX043 (UNIVERSAL PATELLA P3), NX051Z (PS TIBIA CEMENTED T1), NX112(PS PE INSERT T1/T1+,14MM), NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00516, 2916714-2020-00517, 2916714-2020-00518, 2916714-2020-00520.

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

  MAUDE report 10803615 ↗
• 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 PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED BILATERAL 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) 2018. INTRAOPERATIVE FINDINGS SHOWED LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX011Z (PS FEMUR CEMENTED F5N LT). NX042 (UNIVERSAL PATELLA P2). NX051Z (PS TIBIA CEMENTED T1). NX112 (PS PE INSERT T1/T1+, 14MM). NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS PALACOS R RADIOPAQUE BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00545. 2916714-2020-00546. 2916714-2020-00547. 2916714-2020-00549. THE SAME PATIENT HAS AN ADVERSE EVENT / MALFUNCTION FILED UNDER REFERENCE (B)(4) (RIGHT KNEE).

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

  MAUDE report 10803343 ↗