AS VEGA System® PS NX013ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04046963809942), received between Nov 6, 2020 and Sep 8, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE LEFT KNEE FOR LOOSENING OF PRIOR COMPONENTS. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION KNEE SURGERY FOR A LOOSE PATELLAR BUTTON. THE PATELLAR BUTTON WAS REMOVED EASILY WITH A RONGEUR AND OSTEOTOME. A NEW PATELLAR BUTTON WAS NOT IMPLANTED DUE TO INADEQUATE BONE STOCK AND RISK OF LOOSENING. THE FEMORAL AND TIBIAL COMPONENTS WERE ASSESSED AND APPEARED STABLE. THE JOINT WAS IRRIGATED, VANCOMYCIN POWDER WAS PLACED INTRA-ARTICULARLY, AND THE CAPSULE WAS CLOSED. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION. ON (B)(6) 2024, THE PATIENT RETURNED WITH EVIDENCE OF FEMORAL AND TIBIAL COMPONENT LOOSENING. A MIDLINE INCISION AND MEDIAL PARAPATELLAR APPROACH WERE USED. THE TIBIAL COMPONENT WAS REMOVED AFTER CEMENT AT THE BONE INTERFACE WAS DISRUPTED AND THE IMPLANT WAS KNOCKED FREE. THE FEMORAL COMPONENT WAS THEN REMOVED WITH USE OF A SAW AND OSTEOTOME AFTER CIRCUMFERENTIAL RELEASE. APPROXIMATELY ONE-THIRD OF THE FEMUR WAS LOST DURING REMOVAL. AN ANTIBIOTIC-IMPREGNATED SPACER WAS IMPLANTED, AND THE JOINT WAS CLOSED FOLLOWING IRRIGATION AND VANCOMYCIN POWDER APPLICATION. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE COND

  Patient problems: Failure of Implant

  MAUDE report 22993985 ↗
• 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 ANAS VEGA PS FEMORAL COMP.CEMENTED F6N L (ITEM NX013Z) 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 400582827. ASSOCIATE MEDWATCH REPORTS: (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16206248 ↗
• InjuryJan 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE ADVERSE EVEN IS FILED UNDER AAG REFERENCE 100032170 (400582827). ASSOCIATED MEDWATCH-REPORTS: (B)(6) (9610612-2022-00391) - (B)(6). (B)(6) (9610612-2022-00390) - (B)(6). INVOLVED COMPONENTS: (B)(6) - (B)(6) - PLUG F/TIBIAL PLATEAU - LOT 51917990. (B)(6) - (B)(6) - PATELLA 3-PEGS P4 - LOT 51849212. (B)(6) - (B)(6) - VEGA PS GLIDING SURFACE T3/3+ 12MM - LOT 51872457.

  Patient problems: Insufficient Information

  MAUDE report 16199753 ↗
• InjuryApr 1, 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 KNEE IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DIFFICULTY WALKING, AND LOOSENING OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. A REVISION SURGERY WAS NECESSARY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE REPORT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT IS FILED UNDER XC REFERENCE (B)(4). INVOLVED COMPONENTS: NX132 - VEGA PS GLIDING SURFACE T3/3+ 14MM - LOT 51949663. NN260P - PLUG F/TIBIAL PLATEAU - LOT 51974495. NX013Z - AS VEGA PS FEMORAL COMP.CEMENTED F6N L - LOT 51927043. NX055Z (PS TIBIA CEMENTED T3); - LOT 51938561. NX044 - PATELLA 3-PEGS P4 - LOT51911583. CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00307. 2916714-2020-00308. 2916714-2020-00310. 2916714-2020-00311.

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

  MAUDE report 11604234 ↗
• 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: 2916714-2020-00356, 2916714-2020-00357, 2916714-2020-00358, 2916714-2020-00359.

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

  MAUDE report 11415071 ↗
• 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 11117919 ↗
• InjuryDec 22, 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 PAIN, SWELLING IN LEFT KNEE AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY TO LEFT KNEE 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) 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: NX013Z(PS FEMUR CEMENTED F6N LT), NX043 (UNIVERSAL PATELLA P3), NX053Z (PS TIBIA CEMENTED T2), NX121 (PS PE INSERT T2/T2+, 12MM), NN260P(PEEK PLUG F/ TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00651, 2916714-2020-00652, 2916714-2020-00653, 2916714-2020-00654.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11057749 ↗
• 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, 2916714-2020-00558, 2916714-2020-00559.

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

  MAUDE report 10809582 ↗
• 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), VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P) (REF. ASSOCIATED MDR ID 2916714-2020-00528), PS+ GLIDING SURFACE IMPLANT 12MM T3/T3+ (PART # NX131) (REF. ASSOCIATED MDR ID 2916714-2020-00529), 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 # 5

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10804483 ↗