Columbus® CR DD NN1253Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964451751), received between Sep 11, 2024 and Nov 6, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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.

• InjuryNov 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN AESCULAP KNEE IMPLANT SYSTEM (PART # UNKNOWN) WAS IMPLANTED DURING A LEFT TOTAL KNEE REPLACEMENT PROCEDURE SOMETIME IN 2008. REPORTEDLY THE PATIENT HAD UNDERWENT MULTIPLE REVISION PROCEDURES. A REVISION OF THE LEFT TOTAL KNEE REPLACEMENT WAS PERFORMED SOMETIME IN 2011. IN 2013 THE PATIENT UNDERWENT A POLYETHYLENE EXCHANGE OF THE LEFT KNEE SOMETIME DURING (B)(6)2013. A COMPLEX REVISION TO THE LEFT TOTAL KNEE REPLACEMENT, THE FAILED TC3 WAS CONVERTED TO AESCULAP HINGE WAS PERFORMED (B)(6)2015. A LEFT TOTAL KNEE REPLACEMENT WAS PERFORMED ON (B)(6) 2017. THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2019. A REVISION LEFT TOTAL KNEE ARTHROPLASTY FOR FEMORAL COMPONENT FAILURE AND LOOSENING WAS PERFORMED ON (B)(6) 2022. REPORTEDLY THE PATIENT HAS DEVELOPED DEBILITATING SYMPTOMS CONSISTENT WITH TIBIAL COMPONENT LOOSENING AND REQUIRED A REVISION PROCEDURE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 20619484 ↗
• InjuryOct 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS KNEE IMPLANT SYSTEM (PART# UNKNOWN) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE PATIENT WAS SCHEDULED FOR A REVISION PROCEDURE ON (B)(6) 2024. REPORTEDLY THE IMPLANT HAD BECOME LOOSE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00147 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 20416730 ↗
• InjuryOct 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS KNEE IMPLANT SYSTEM (PART# UNKNOWN) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE PATIENT WAS SCHEDULED FOR A REVISION PROCEDURE ON (B)(6) 2024. REPORTEDLY THE IMPLANT HAD BECOME LOOSE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC 100037235 CC (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00146 (AIC REFERENCE NO. (B)(4)) 2916714-2024-00147 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 20416727 ↗
• InjurySep 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF THE COLUMBUS KNEE IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, POSTOPERATIVELY PATIENT DEVICE INTERACTION WAS PROBLEMATIC. A POLYETHYLENE SWAP WAS SCHEDULED FOR ON (B)(6) 2024. THE ADVERSE EVENT IS FILED UNDER AESCULAP REFERENCE NUMBER: (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 20327004 ↗
• InjurySep 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF THE COLUMBUS KNEE IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, POSTOPERATIVELY PATIENT DEVICE INTERACTION WAS PROBLEMATIC. A POLYETHYLENE SWAP WAS SCHEDULED FOR (B)(6) 2024. THE ADVERSE EVENT IS FILED UNDER AESCULAP REFERENCE NUMBER (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 20326124 ↗
• InjurySep 11, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS KNEE IMPLANT SYSTEM WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THERE WAS AN ISSUE WITH ONE OF THE COMPONENTS. REPORTEDLY A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THE POLYETHYLENE COMPONENTS WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE NUMBER (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 20188811 ↗