Columbus® REVISION F NR076KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963338169), received between Aug 23, 2021 and Oct 21, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 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 NR076K - COLUMBUS REV F TIBIA OFFSET CEMENTED T3+. IT WAS REPORTED ON (B)(6) 2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED LOOSENESS IN THE IMPLANT, PAIN AND DIFFICULTY WALKING, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, 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. CEMENT USED: BIOMET MV BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00455 (400481542 + (B)(4)). INVOLVED COMPONENTS: NR015K - COLUMBUS REV F FEMUR CEMENTED F5R - 51869643. NR296K - FEMUR EXTENS.STEM 6° D18X157MM CEMENTED - 51622420. NR400K - NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR. - 52032922. NR196K - TIBIA OFFSET STEM D18X92MM CEMENTED - 51681838. NR133M - COLUMBUS REV F MC GLID.SURF.T3/3+ 16MM - 51885048. NR134M - COLUMBUS REV F MC GLID.SURF.T3/3+ 18MM - 52068453.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 12676470 ↗
• InjuryAug 23, 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 NR076K - COLUMBUS REV F TIBIA OFFSET CEMENTED T3+. IT WAS REPORTED ON (B)(6) 2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED LOOSENESS IN THE IMPLANT, PAIN AND DIFFICULTY WALKING, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, 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. CEMENT USED: BIOMET MV BONE CEMENT. A REVISION SURGERY WAS NECESSARY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00455 (400481542 + NR015K). INVOLVED COMPONENTS: NR015K - COLUMBUS REV F FEMUR CEMENTED F5R - 51869643. NR296K - FEMUR EXTENS.STEM 6¿ D18X157MM CEMENTED - 51622420. NR400K - NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR. - 52032922. NR196K - TIBIA OFFSET STEM D18X92MM CEMENTED - 51681838. NR133M - COLUMBUS REV F MC GLID.SURF.T3/3+ 16MM - 51885048.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain

  MAUDE report 12355678 ↗