AS Columbus® REVISION F NR071ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046963175948), received between Oct 11, 2021 and Aug 28, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 22913044 ↗
• InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS COLUMBUS REV F TIB.OFFSET CEMENT.T1 (PART# NR071Z) 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, 3005673311-2025-00022, 3005673311-2025-00023, 3005673311-2025-00024, 3005673311-2025-00025, 3005673311-2025-00026, 3005673311-2025-00027, 3005673311-2025-00028, 3005673311-2025-00029, 3005673311-2025-00030.

  Patient problems: Failure of Implant

  MAUDE report 21755137 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP AG THAT A AS TIBIA OFFSET STEM D12X52MM CEMENTED. (PART # NR191Z) 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: (B)(4) - NR191Z (9610612-2022-00142); (B)(4) - NR291Z (9610612-2022-00143); (B)(4) - NR565Z (9610612-2022-00144); (B)(4) - NR565Z (9610612-2022-00145); (B)(4) - NR611M (9610612-2022-00146); (B)(4) - NR005Z (9610612-2022-00148); (B)(4)- NR400Z (9610612-2022-00149).

  Patient problems: Failure of Implant

  MAUDE report 14456572 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV F TIB. OFFSET CEMENT. T1 (PART # NR071Z) 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: 400554585: NR191Z, (2916714-2022-00055), 400554586: NR291Z, (2916714-2022-00056), 400554587: NR565Z, (2916714-2022-00057), 400554588: NR565Z, (2916714-2022-00058), 400554589: NR611M, (2916714-2022-00059), 400554591: NR005Z, (2916714-2022-00061), 400554592: NR400Z, (2916714-2022-00062).

  Patient problems: Failure of Implant

  MAUDE report 14456074 ↗
• InjuryOct 11, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS REV F TIB.OFFSET CEMENT.T1 (PART # NR071Z-AS) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE CEMENTING PROCESS OF THE TIBIA TRAY AND STEM, THE CEMENT WORKED ITS WAY INTO THE TIBIA BASEPLATE. THE CEMENT ENTERED THE TIBIA TRAY AT THE JUNCTION OF THE INFERIOR SIDE OF THE TIBIA TRAY. THE CEMENT OBSTRUCTED THE THREADED SCREW HOLE FOR THE TIBIAL INSERT SCREW. REPORTEDLY, THE SURGEON SPENT EXTRA TIME REMOVING THE HARDENED CEMENT FROM THE SMALL SCREW HOLE BEFORE THE SCREW WAS ABLE TO BE PLACED. HOWEVER, THE SURGEON WAS ABLE TO CLEAR THE CEMENT AND INSERT THE SCREW, AND THEN THE PROCEDURE WAS ABLE TO BE CONTINUED AND SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610661 ↗
• InjuryOct 11, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS REV F TIB.OFFSET CEMENT.T1 (PART # NR071Z-AS) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE CEMENTING PROCESS OF THE TIBIA TRAY AND STEM, THE CEMENT WORKED ITS WAY INTO THE TIBIA BASEPLATE. THE CEMENT ENTERED THE TIBIA TRAY AT THE JUNCTION OF THE INFERIOR SIDE OF TIBIA TRAY. THE CEMENT OBSTRUCTED THE THREADED SCREW HOLE FOR THE TIBIAL INSERT SCREW. REPORTEDLY, THE SURGEON SPENT EXTRA TIME REMOVING THE HARDENED CEMENT FROM THE SMALL SCREW HOLE BEFORE THE SCREW WAS ABLE TO BE PLACED. HOWEVER, THE SURGEON WAS ABLE TO CLEAR THE CEMENT AND INSERT THE SCREW. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605085 ↗