AS VEGA System® PS NX033ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04046963810207), received between Apr 3, 2018 and Mar 19, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 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 13 most recent of 13 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 FAILURE OF A KNEE PROSTHESIS SYSTEM THAT REQUIRED REVISION SURGERY. POSTOPERATIVE LOOSENING OF AN AESCULAP KNEE IMPLANT WAS ALLEGEDLY REPORTED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24637495 ↗
• InjuryOct 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT THERE WAS AN ISSUE WITH THE AESCULAP CERAMIC-COATED KNEE IMPLANT. REPORTEDLY THE KNEE IMPLANT WAS DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT. THE INDEX SURGERY WAS PERFORMED SOMETIME IN (B)(6) 2018 REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 23193461 ↗
• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE RIGHT KNEE FOR LOOSENING OF PRIOR COMPONENTS. THE FEMORAL COMPONENT WAS REMOVED USING A MICROCHOICE AND OSTEOTOME WITH MINIMAL BONE LOSS. THE TIBIA WAS SUBLUXED FORWARD AND A MICROCHOICE WAS USED ABOUT THE PROSTHESIS TO LOOSEN IT. THE TIBIAL COMPONENT WAS ABLE TO BE REMOVED WITH MINIMAL BONE LOSS. TRIAL COMPONENTS WERE PLACED, AND STABLE FIXATION WITH ACCEPTABLE FLEXION/EXTENSION WAS ACHIEVED. A POLYETHYLENE INSERT WAS PLACED, AND THE JOINT WAS COPIOUSLY IRRIGATED. THE PATIENT TOLERATED THE PROCEDURE, WAS AWAKENED FROM ANESTHESIA, AND TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 22992552 ↗
• InjuryJun 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE RIGHT KNEE FOR LOOSENING OF PRIOR COMPONENTS. A MIDLINE INCISION AND MEDIAL PARAPATELLAR APPROACH WERE PERFORMED, AND THE FEMORAL AND TIBIAL BONE WERE PREPARED USING STANDARD INSTRUMENTS. THE FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED USING THIRD-GENERATION CEMENT TECHNIQUE (VACUUM SEALED). A TIBIAL TRAY AND POLYETHYLENE INSERT WERE PLACED, FOLLOWED BY PATELLAR BUTTON PLACEMENT. DURING THE PROCEDURE, BONE CUTS, TRIALING, AND IMPLANTATION PROCEEDED AS EXPECTED WITH NO REPORTED INTRAOPERATIVE COMPLICATIONS. FINAL INSPECTION CONFIRMED APPROPRIATE FIT AND STABILITY OF THE COMPONENTS, WITH NO EVIDENCE OF MALALIGNMENT OR IMPROPER FIXATION. THE PATIENT TOLERATED THE PROCEDURE, WAS AWAKENED FROM ANESTHESIA, AND TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 22205754 ↗
• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INVESTIGATION COMPLETE.

  Patient problems: Failure of Implant

  MAUDE report 16207533 ↗
• InjuryJan 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ASSOCIATED MEDWATCH-REPORTS: 400582818 (9610612-2022-00392) - NX055Z, 400582821 (9610612-2022-00393) - NX033Z. INVOLVED COMPONENTS: 400582819 - NX044 - PATELLA 3-PEGS P4 LOT 51849212. 400582820 - NX132 - VEGA PS GLIDING SURFACE T3/3+ 14MM - LOT 51901306. 400582822 - NN260P - PLUG F/TIBIAL PLATEAU - LOT 51910799.

  Patient problems: Insufficient Information

  MAUDE report 16198981 ↗
• InjuryJan 21, 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 RIGHT KNEE AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY TO RIGHT 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. THE CEMENT USED DURING PROCEDURE IS UNAVAILABLE. 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: NX033Z(PS FEMUR CEMENTED F6N RT), NX043 (UNIVERSAL PATELLA P3), NX053Z (PS TIBIA CEMENTED T2), NX120 (PS PE INSERT T2/T2+, 10MM), NN260P(PEEK PLUG F/ TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00655, 2916714-2020-00656, 2916714-2020-00657, 2916714-2020-00658, 2916714-2020-00659.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11210144 ↗
• 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, RIGHT 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) 2016. 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: NX033Z (PS FEMUR CEMENTED F6N RT), NX044 (UNIVERSAL PATELLA P4), NX055Z (PS TIBIA CEMENTED T3), NX132 (PS PE INSERT T3/T3+, 14MM), 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: 2916714-2020-00512, 2916714-2020-00513, 2916714-2020-00514, 2916714-2020-00515.

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

  MAUDE report 11118528 ↗
• 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), 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) (REF. ASSOCIATED MDR ID 2916714-2020-00593), 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 10823644 ↗
• 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 KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING, DIFFICUILTY WALKING AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2017 AND THERE WAS NO REPORTED REVISION SURGERY. CEMENT USED: DEPURY SMARTSET GHV 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: NN264Z (TIBIAL OBTURATOR D14MM L7MM). NX057Z (PS TIBIA CEMENTED T4). NX033Z (PS FEMUR CEMENTED F6N RT). NX240(PS+PE INSERT T4/T4+,10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00565. 2916714-2020-00566. 2916714-2020-00568.

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

  MAUDE report 10812134 ↗
• 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; 2916714-2020-00478; 2916714-2020-00479; 2916714-2020-00480.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10653205 ↗
• 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, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2014 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 XC (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00379, 2916714-2020-00380, 2916714-2020-00381, 2916714-2020-00382. INVOLVED COMPONENTS: NX033Z (PS FEMUR CEMENTED F6N RT), NX057Z (PS TIBIA CEMENTED T4), NN264Z (TIBIAL OBTURATOR D14MM, L7MM), NX140 (PS PE INSERT T4/T4+, 10MM), NX043 (UNIVERSAL PATELLA P3). CEMENT: ZIMMER PALACOS R+G RADIOPAQUE BONE CEMENT (00-1113-140-01).

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10601302 ↗
• MalfunctionApr 3, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  COUNTRY OF COMPLAINT: USA. RECEIVED VIA MEDWATCH (MW5075187): EVENT DESCRIPTION PER MW REPORT: GLOBAL FAILURE TOTAL KNEE REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FILE WILL BE UPDATED WHEN INFORMATION IS RECEIVED. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00167.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7394123 ↗