Refobacin® Bone Cement R 110034355Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00880304990197), received between Jan 2, 2020 and Sep 10, 2026 — classified as 61 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent an initial right knee arthroplasty. Subsequently, approximately seventeen months post-implantation, the patient underwent revision surgery due to loosening of the femoral component.Due diligence is in progress for this complaint; no further information has been received at the time of this report.

  Patient problems: Aseptic loosening

  MAUDE report 50715472 ↗
• InjuryOct 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY FOUR MONTHS POST INITIAL SURGERY ON THE RIGHT KNEE AS THE LOCKING BAR ON THE TIBIAL COMPONENT CAME LOOSE AND MIGRATED LATERALLY. THE SALES REP IS UNSURE IF THE LOCKING BAR WAS FULLY LOCKED INTO PLACE DURING THE INITIAL SURGERY. DURING THE REVISION, THE SURGEON PULLED THE LOCKING BAR OUT AND ONLY REPLACED THIS PIECE. THEY DID NOT REVISE ANY OTHER COMPONENTS. THE PATIENT WAS EXPERIENCING PAIN PRIOR TO THE REVISION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23288934 ↗
• InjuryOct 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 4 MONTHS POST-IMPLANTATION DUE TO LOOSE TIBIAL LOCKING BAR. THE DEVICE WAS EXCHANGED WITHOUT ANY KNOWN COMPLICATIONS, AND ALL OTHER INITIAL COMPONENTS WERE ABLE TO REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23288820 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Erythema; Loss of Range of Motion; Pain; Rash; Swelling/ Edema

  MAUDE report 23013709 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE TWO-YEAR FOLLOW-UP FOLLOWING AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT REPORTED EXPERIENCING PAIN. THIS PAIN HAS PERSISTED THROUGH TO THE MOST RECENT FOLLOW-UP, CONDUCTED FOUR YEARS POST THE INITIAL PROCEDURE. ALL RADIOGRAPHIC IMAGING REVEALED NO SIGNIFICANT FINDINGS, AND ALL IMPLANTED COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER ADDITIONAL EVENT INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 22086064 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE TWO-YEAR FOLLOW-UP FOLLOWING AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT REPORTED EXPERIENCING PAIN. THIS PAIN HAS PERSISTED THROUGH TO THE MOST RECENT FOLLOW-UP, CONDUCTED FOUR YEARS POST THE INITIAL PROCEDURE. ALL RADIOGRAPHIC IMAGING REVEALED NO SIGNIFICANT FINDINGS, AND ALL IMPLANTED COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER ADDITIONAL EVENT INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 22086061 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE TWO-YEAR FOLLOW-UP FOLLOWING AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT REPORTED EXPERIENCING PAIN. THIS PAIN HAS PERSISTED THROUGH TO THE MOST RECENT FOLLOW-UP, CONDUCTED FOUR YEARS POST THE INITIAL PROCEDURE. ALL RADIOGRAPHIC IMAGING REVEALED NO SIGNIFICANT FINDINGS, AND ALL IMPLANTED COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER ADDITIONAL EVENT INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 22086059 ↗
• InjuryMay 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE REACTION. TREATMENT/INTERVENTION REMAINS UNKNOWN. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 22059621 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR HEMATOMA EVACUATION. A SIGNIFICANT HEMATOMA WAS NOTED, EVACUATED, AND A DRAIN WAS PLACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Hematoma

  MAUDE report 21751250 ↗
• InjuryMar 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY THREE YEARS AGO. SUBSEQUENTLY, PATIENT REPORTED PAIN AND DISLOCATION OF THE LEFT KNEE. A REVISION PROCEDURE WAS SCHEDULED HOWEVER IT WAS NOT CONFIRMED IF IT OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 21718970 ↗
• InjuryMar 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY THREE YEARS AGO. SUBSEQUENTLY, PATIENT REPORTED PAIN AND DISLOCATION OF THE LEFT KNEE. A REVISION PROCEDURE WAS SCHEDULED HOWEVER IT WAS NOT CONFIRMED IF IT OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 21718963 ↗
• InjuryMar 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY SEVEN MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. DURING THE REVISION, SEVERE POLYETHYLENE SYNOVITIS AND GROSSLY LOOSE AND SUBSIDED TIBIA WERE NOTED. THE FEMUR WAS NOTED TO BE WELL FIXED HOWEVER, REVISED TO ENSURE BALANCE OF THE KNEE. PATELLA WAS INTACT AND NOT RESURFACED. FEMUR, TIBIA, AND ARTICULAR SURFACE WERE REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 21718479 ↗
• InjuryMar 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY SEVEN MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. DURING THE REVISION, SEVERE POLYETHYLENE SYNOVITIS AND GROSSLY LOOSE AND SUBSIDED TIBIA WERE NOTED. THE FEMUR WAS NOTED TO BE WELL FIXED HOWEVER, REVISED TO ENSURE BALANCE OF THE KNEE. PATELLA WAS INTACT AND NOT RESURFACED. FEMUR, TIBIA, AND ARTICULAR SURFACE WERE REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 21718455 ↗
• InjuryMar 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY SIXTEEN MONTHS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENING OF THE RIGHT TIBIAL COMPONENT. DURING THE REVISION SYNOVITIS AND OSTEOLYSIS WERE NOTED. THE TIBIAL COMPONENT WAS GROSSLY LOOSE AND HAD COMPLETELY DEBONED FROM THE CEMENT INTERFACE. PATELLA WAS RETAINED ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21717917 ↗
• InjuryMar 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY SIXTEEN MONTHS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENING OF THE RIGHT TIBIAL COMPONENT. DURING THE REVISION SYNOVITIS AND OSTEOLYSIS WERE NOTED. THE TIBIAL COMPONENT WAS GROSSLY LOOSE AND HAD COMPLETELY DEBONED FROM THE CEMENT INTERFACE. PATELLA WAS RETAINED ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21717913 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, FOUR YEARS AFTER THE INITIAL PROCEDURE, THE PATIENT WAS REVISED DUE TO SUBSIDENCE OF THE TIBIAL IMPLANT. DURING THE REVISION IT WAS NOTED THAT THE TIBIAL IMPLANT HAD SUBSIDED INTO EXTENSION VARUS, SEVERE SYNOVITIS, AND OSTEOLYSIS. THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 21713771 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, FOUR YEARS AFTER THE INITIAL PROCEDURE, THE PATIENT WAS REVISED DUE TO SUBSIDENCE OF THE TIBIAL IMPLANT. DURING THE REVISION IT WAS NOTED THAT THE TIBIAL IMPLANT HAD SUBSIDED INTO EXTENSION VARUS, SEVERE SYNOVITIS, AND OSTEOLYSIS. THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 21713765 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR HEMATOMA EVACUATION. A SIGNIFICANT HEMATOMA WAS NOTED, EVACUATED, AND A DRAIN WAS PLACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: Hematoma

  MAUDE report 21695277 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hematoma

  MAUDE report 21695276 ↗
• InjuryFeb 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT HAD A RIGHT TOTAL ELBOW ARTHROPLASTY FOLLOWED BY A REVISION DUE TO PAIN AND ULNAR LOOSENING. SUBSEQUENTLY, UNDERWENT A SECOND REVISION DUE TO LOOSENING OF THE ULNAR AND HUMERAL IMPLANTS. A COMPETITOR, CUSTOM MADE, ULNAR IMPLANT AND A ZB HUMERAL IMPLANT WERE PLACED. APPROXIMATELY 5 YEARS AND 1 MONTHS POST-IMPLANTATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21419669 ↗
• InjuryFeb 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21419667 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bacterial Infection; Hematoma; Impaired Healing; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 21374616 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT, WHO HAS UNDERGONE MULTIPLE SURGERIES RELATED TO A LEFT ELBOW ARTHROPLASTY, IS CURRENTLY EXPERIENCING COMPLICATIONS THAT INCLUDE PERSISTENT ELBOW EFFUSION, PAIN, LUCENCY, AND CHRONIC INFECTIONS. DESPITE LONG-TERM ANTIBIOTIC TREATMENT, THE ELBOW REMAINS "USELESS," PROMPTING THE NEED FOR FURTHER REVISION SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bacterial Infection; Fungal Infection; Joint effusion; Pain; Radiolucent Lines; Unspecified Infection

  MAUDE report 21110141 ↗
• InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20829816 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bursitis; Pain

  MAUDE report 20265849 ↗