CARDINAL HEALTH CMT-40-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885380066511), received between Feb 13, 2017 and Sep 14, 2020 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2018, (B)(6) UNDERWENT LEFT-SIDED TOTAL KNEE REPLACEMENT SURGERY PERFORMED BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6). HE WAS IMPLANTED WITH BIOMET VANGUARD COMPONENTS. ON (B)(6) 2018, IN ORDER TO BOND THESE COMPONENTS, DR. (B)(6) UTILIZED THE DEFECTIVE CARDINAL HV BONE CEMENT. AFTER THE CARDINAL HV BONE CEMENT WAS IMPLANTED, MR. (B)(6) BEGAN EXPERIENCING SEVERE AND PERSISTENT PAIN, DISCOMFORT, INSTABILITY AND DIFFICULTY AMBULATING DUE TO ASEPTIC LOOSENING. ON (B)(6) 2019, PATIENT UNDERWENT REVISION SURGERY DUE TO GROSS LOOSENING OF HIS KNEE COMPONENTS IN HIS LEFT KNEE. THIS SURGERY WAS PERFORMED BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6). IN THIS PROCEDURE, DR. (B)(6) ASSESSED THE IMPLANT COMPONENTS AND FOUND "GROSS LOOSENING OF THE TIBIAL COMPONENT." NO X-RAYS ARE AVAILABLE. NO FURTHER INFORMATION HAVE BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10527111 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6)2016, MS. (B)(6) UNDERWENT TOTAL LEFT KNEE REPLACEMENT BY IMPLANTING SURGEON, DR. (B)(6) WITH CARDINAL HEALTH ARTHROPLASTY BONE CEMENT. ON (B)(6) 2019, MS. (B)(6) TO UNDERGO UNDERGO A REVISION SURGERY DUE TO ASEPTIC LOOSENING OF HIS ARTIFICIAL KNEE COMPONENTS. NO X-RAYS ARE AVAILABLE. NO FURTHER INFORMATION HAVE BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10028062 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2016, MR. (B)(6) UNDERWENT BILATERAL TOTAL KNEE REPLACEMENTS BY IMPLANTING SURGEON, DR. (B)(6) WITH CARDINAL HEALTH ARTHROPLASTY BONE CEMENT. ON (B)(6) 2017, MR. (B)(6) TO UNDERGO A RIGHT-SIDED REVISION SURGERY DUE TO ASEPTIC LOOSENING OF HIS ARTIFICIAL KNEE COMPONENTS. SIMILARLY, ON (B)(6) 2018, MR. (B)(6) UNDERGO A LEFT-SIDED REVISION SURGERY DUE TO ASEPTIC LOOSENING OF HIS ARTIFICIAL KNEE COMPONENTS. NO X-RAYS ARE AVAILABLE. NO FURTHER INFORMATION HAVE BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10028060 ↗
• MalfunctionFeb 13, 2017Inadequate or Insufficient Training; Device Handling Problem; Inadequate or Insufficient Training; Device Handling Problem

  MIXINNG TIME: 90 SECOUNDS; BONE CEMENT IMPLANTATION AFTER 2:20 MINUTES; TIBIA PLATE IMPLANTATION AFTER 3:20 MINUTES; CURING TIME 15 MINUTES (LONGER THAN EXPECTED). DELAY IN SURGERY (SOME MINUTES).

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 6325164 ↗
• MalfunctionFeb 13, 2017Inadequate or Insufficient Training; Device Handling Problem; Inadequate or Insufficient Training; Device Handling Problem

  MIXINNG TIME: 90 SECONDS; BONE CEMENT IMPLANTATION AFTER 2:38 MINUTES; TIBIA PLATE IMPLANTATION AFTER 3:30 MINUTES; CURING TIME 15 MINUTES (LONGER THAN EXPECTED); DELAY IN SURGERY (SOME MINUTES).

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 6325161 ↗
• MalfunctionFeb 13, 2017Inadequate or Insufficient Training; Device Handling Problem; Inadequate or Insufficient Training; Device Handling Problem

  MIXING TIME: 50 SECONDS; IMPLANTATION OF BONE CEMENT INTO FEMUR AFTER 2:04 MINUTES; INSERT OF FEMORAL COMPONENT AFTER 4:48 MINUTES; 15 MINUTES FLEXED KNEE (CEMENT CURED); DELAY IN SURGERY (SOME MINUTES).

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 6325129 ↗
• MalfunctionFeb 13, 2017Inadequate or Insufficient Training; Device Handling Problem; Inadequate or Insufficient Training; Device Handling Problem

  MIXING TIME: 25 SECONDS; WAITING TIME: 32 SECONDS; IMPLANTATION OF TIBIA BASE PLATE AFTER 2:06 MINUTES; CEMENT WAS TOO THIN FOR IMPLANTATION AND HAS NOT REACHED THE DOUGH STATE USAGE, CEMENT RAN DOWN THE LEG. DELAY IN SURGERY (SOME MINUTES).

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 6325128 ↗