AS NR400ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04046963367732), received between Oct 14, 2020 and May 1, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Patient-Device Incompatibility

  A LAW FIRM REPORTS THAT A PATIENT ALLEGES POST-OPERATIVE LOOSENING OF AESCULAP KNEE IMPLANT. REPORTEDLY THERE WAS ALLEGED PAIN AND SWELLING 1 YEAR, 5 MONTHS POST OPERATIVE AFTER THE REVISION OF THE LEFT KNEE. THE ADVERSE EVENT IS FILED UNDER AIS REFERENCE: (B)(4).

  Patient problems: Implant Pain

  MAUDE report 25055812 ↗
• InjuryMar 23, 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 (B)(6) 2022, A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. THE PROCEDURE WAS PERFORMED USING CEMENTED KNEE COMPONENTS (AESCULAP SYSTEM) WITH PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO INTRAOPERATIVE COMPLICATIONS, AND THE IMPLANTS WERE PLACED WITH APPROPRIATE ALIGNMENT AND STABILITY. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED (B)(6) 2023, THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. INTRAOPERATIVELY, BOTH COMPONENTS WERE NOTED TO BE GROSSLY LOOSE, WITH NO CEMENT ADHERENT TO THE IMPLANTS. THE COMPONENTS WERE REMOVED WITHOUT SIGNIFICANT BONE LOSS. REVISION WAS PERFORMED USING STEMMED FEMORAL AND TIBIAL COMPONENTS, BONE CEMENT, AND ADJUNCTIVE MATERIALS INCLUDING ANTIBIOTIC BEADS. FINAL IMPLANTATION DEMONSTRATED STABLE FIXATION WITH APPROPRIATE ALIGNMENT AND FULL RANGE OF MOTION WITHOUT INSTABILITY. THE PATIENT TOLERATED THE PROCEDURE AND W

  Patient problems: Failure of Implant

  MAUDE report 24661560 ↗
• InjuryAug 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2023.

  Patient problems: Implant Pain; Metal Related Pathology

  MAUDE report 22913060 ↗
• InjuryJun 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2017, WITH IMPLANTATION OF A VEGA SYSTEM IN THE RIGHT KNEE. THE TIBIAL COMPONENT REPORTEDLY LOOSENED AND REQUIRED REVISION ON (B)(6) 2018, AT WHICH TIME THE VEGA SYSTEM WAS AGAIN USED FOR THE BOTTOM COMPONENT. ON (B)(6) 2019, A SECOND REVISION WAS PERFORMED AFTER THE FEMORAL COMPONENT REPORTEDLY FAILED, AND THE CONSTRUCT WAS REVISED TO A COLUMBUS AF SYSTEM. DESPITE THE REVISIONS, THE PATIENT CONTINUED TO EXPERIENCE INSTABILITY AND PAIN. ON (B)(6) 2022, A THIRD REVISION WAS PERFORMED, AND ALL AESCULAP COMPONENTS WERE REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. WHILE NO FURTHER MECHANICAL FAILURE HAS OCCURRED SINCE THAT SURGERY, THE PATIENT CONTINUES TO REPORT CHRONIC SWELLING, PAIN, AND LIMITED MOBILITY IN THE RIGHT KNEE. THE RIGHT KNEE IS NOW VISIBLY LARGER THAN THE LEFT, AND THE PATIENT REQUIRED A LEFT KNEE REPLACEMENT DUE TO OVERCOMPENSATION. THE EXPLANTED RIGHT KNEE COMPONENTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 22306730 ↗
• InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR. (PART# NR400Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT A SURGERY TO REPLACE THE POLYETHYLENE COMPONENTS HAD BEEN PLANNED FOR (B)(6) 2025; SIZES LARGER THAN 20 MILLIMETER (MM) NEEDED. THE PROCEDURE WOULD BE REVISION RIGHT KNEE TOTAL ARTHROPLASTY (TKA). ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00019, 3005673311-2025-00020, 3005673311-2025-00021, 3005673311-2025-00022, 3005673311-2025-00023, 3005673311-2025-00024, 3005673311-2025-00025, 3005673311-2025-00026, 3005673311-2025-00027, 3005673311-2025-00028, 3005673311-2025-00030.

  Patient problems: Failure of Implant

  MAUDE report 21755164 ↗
• InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS NUT F/FEMUR EXTENS. STEM ALL SZ. NEUTR. (PART# NR400Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT A SURGERY TO REPLACE THE POLYETHYLENE COMPONENTS HAD BEEN PLANNED FOR (B)(6) 2025; SIZES LARGER THAN 20 MILLIMETERS (MM) NEEDED. THE PROCEDURE WOULD BE REVISION RIGHT KNEE TOTAL ARTHROPLASTY (TKA). ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00019. 3005673311-2025-00020. 3005673311-2025-00021. 3005673311-2025-00022. 3005673311-2025-00023. 3005673311-2025-00024. 3005673311-2025-00025. 3005673311-2025-00026. 3005673311-2025-00027. 3005673311-2025-00029. 3005673311-2025-00030.

  Patient problems: Failure of Implant

  MAUDE report 21755126 ↗
• InjuryApr 1, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV FEM.SPACER DIST.F6 5MM (PART# NR400Z) WAS IMPLANTED ON (B)(6) 2021. ACCORDING TO THE COMPLAINT DESCRIPTION, A SURGERY TO REPLACE THE POLYETHYLENE COMPONENT(S) HAD BEEN PLANNED. DEBRIDEMENT OF SCARRING ON THE RIGHT KNEE WOULD ALSO BE PERFORMED. THE PATIENT EXPERIENCED DECREASED RANGE OF MOTION IN THE RIGHT KNEE AND PAIN. THE POLYETHYLENE REPLACEMENT WOULD LIKELY BE SMALLER IN SIZE. THE PROCEDURE WAS PLANNED FOR (B)(6) 2025. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00010. 3005673311-2025-00011. 3005673311-2025-00012. 3005673311-2025-00013. 3005673311-2025-00015. 3005673311-2025-00016. 3005673311-2025-00017. 3005673311-2025-00018.

  Patient problems: Loss of Range of Motion

  MAUDE report 21741324 ↗
• InjuryNov 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS NUT F/FEMUR EXTENS.STEM ALL SZ. NEUTR. (PART # NR400Z) WAS IMPLANTED IN A PATIENT ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT THE PATIENT CURRENTLY PRESENTS WITH TIBIAL BASE PLATE LOOSENING AND CONTINUED LEFT PAINFUL KNEE ARTHROPLASTY. REPORTEDLY A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2024. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4)). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00186 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00187 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00188 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00189 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00190 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00191 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 20722449 ↗
• InjuryOct 29, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP INC. THAT A AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR. (PART # NR400Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE PATIENT WAS INFECTED AND REQUIRED A REVISION PROCEDURE. REPORTEDLY THE REVISION WAS PERFORMED ON (B)(6) 2024. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00162, (AIC REFERENCE NO. (B)(4) ). 2916714-2024-00165, (AIC REFERENCE NO. (B)(4) ). 2916714-2024-00166, (AIC REFERENCE NO. (B)(4) ). 2916714-2024-00167, (AIC REFERENCE NO. (B)(4) ). 2916714-2024-00168, (AIC REFERENCE NO. (B)(4) ). 2916714-2024-00169, (AIC REFERENCE NO. (B)(4) ). 2916714-2024-00171, (AIC REFERENCE NO. (B)(4) ). 2916714-2024-00172, (AIC REFERENCE NO. (B)(4) ). 2916714-2024-00173, (AIC REFERENCE NO. (B)(4) ). (AIC REFERENCE NO. (B)(4) ). 2916714-2024-00175, (AIC REFERENCE NO. (B)(4) ).

  Patient problems: Failure of Implant; Implant Pain; Unspecified Infection

  MAUDE report 20561163 ↗
• InjuryOct 14, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS NUT F/FEMUR EXTENS.STEM ALL SZ. NEUTR. (PART# NR400Z) WAS IMPLANTED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT THE IMPLANT WAS TOO TIGHT. REPORTEDLY THE PATIENT IS SCHEDULED FOR A REVISION SURGERY ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). 2916714-2024-00151 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00152 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00153 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00154 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00155 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00156 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00157 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00158 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 20446816 ↗
• InjuryJun 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INVESTIGATION COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 17074625 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP INC. THAT A AS NUT F/FEMUR EXTENS. STEM ALL SZ. NEUTR. (PART # NR400Z) WAS IMPLANTED DURING A LEFT KNEE REVISION SURGERY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, POST-OPERATIVE BONE DETERIORATION OF FEMUR AND TIBIA OCCURRED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. ACCORDING TO THE PATIENT , A REVISION SURGERY IN THE FUTURE IS LIKELY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) - NR191Z (2916714-2022-00055). (B)(4) - NR291Z (2916714-2022-00056). (B)(4) - NR565Z (2916714-2022-00057). (B)(4) - NR565Z (2916714-2022-00058). (B)(4) - NR611M (2916714-2022-00059). (B)(4) - NR071Z (2916714-2022-00060). (B)(4) - NR005Z (2916714-2022-00061). (B)(4) - NR400Z (2916714-2022-00062).

  Patient problems: Failure of Implant

  MAUDE report 14456282 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP AG THAT A AS NUT F/FEMUR EXTENSSTEM ALL SZ.NEUTR. (PART # NR400Z) WAS IMPLANTED DURING A LEFT KNEE REVISION SURGERY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, POST-OPERATIVE BONE DETERIORATION OF FEMUR AND TIBIA OCCURRED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. A REVISION IN THE FUTURE IS LIKELY, ACCORDING TO THE PATIENT. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 400554585 - NR191Z (9610612-2022-00142). 400554586 - NR291Z (9610612-2022-00143). 400554587 - NR565Z (9610612-2022-00144). 400554588 - NR565Z (9610612-2022-00145). 400554589 - NR611M (9610612-2022-00146). 400554590 - NR071Z (9610612-2022-00147). 400554591 - NR005Z (9610612-2022-00148). 400554592 - NR400Z (9610612-2022-00149).

  Patient problems: Failure of Implant

  MAUDE report 14456062 ↗
• InjuryJul 8, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO UPDATES REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12137706 ↗
• InjuryOct 14, 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 COLUMBUS KNEE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLLING, DIFFICULTY WALKING AND LOOSENING OF THE DEVICE. THE PRIMARY PROCEDURE OCCURRED ON AN UNSPECIFIED DATE, AND THE REVISION WAS PERFORMED ON (B)(6) 2017. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NR003Z (PS FEMUR CEMENTED F3L), NR400Z (FEMUR STEM NUT ALL SIZES NEUTRAL), NR291Z (FEMORAL STEM CEMENTED 6° NEUT D12X77MM), NR072Z (PS TIBIA CEMENTED T1+), NR191Z (TIBIAL OFFSET STEM CEMENTED D12X52MM), NR614M (PS HC PE INSERT T1/T1+ 18MM). THE CEMENT USED IS UNIDENTIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00465, 2916714-2020-00466, 2916714-2020-00467, 2916714-2020-00468, 2916714-2020-00469, 2916714-2020-00470.

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

  MAUDE report 10679354 ↗