AS NR191ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963176105), received between Oct 14, 2020 and May 20, 2022 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP INC. 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. 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: 400554586 - NR291Z (2916714-2022-00056), 400554587 - NR565Z (2916714-2022-00057), 400554588 - NR565Z (2916714-2022-00058), 400554589 - NR611M (2916714-2022-00059), 400554590 - NR071Z (2916714-2022-00060), 400554591 - NR005Z (2916714-2022-00061), AND 400554592 - NR400Z (2916714-2022-00062).

  Patient problems: Failure of Implant

  MAUDE report 14456349 ↗
• 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. ACCORDING TO THE PATIENT , A REVISION SURGERY IN THE FUTURE IS LIKELY. 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) - NR071Z (9610612-2022-00147), (B)(4) - NR005Z (9610612-2022-00148), (B)(4) - NR400Z (9610612-2022-00149).

  Patient problems: Failure of Implant

  MAUDE report 14456344 ↗
• 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, 2916714-2020-00470.

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

  MAUDE report 10679348 ↗