NA 1294-53-245Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295026358), received between Jan 11, 2019 and Dec 12, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A KNEE REVISION. WE HAVE REVISED A NOILES FEMUR WHICH APPEARS TO HAVE SNAPPED AT THE BASE OF THE FEMORAL COMPONENT AND THE SLEEVE THE PROCEDURE WAS DONE 9 YEARS AGO. IT IS THE 3RD TIME THIS PATIENT HAS BEEN REVISED.

  Patient problems: Insufficient Information

  MAUDE report 23791579 ↗
• InjuryDec 2, 2025Fracture; Fracture

  IT WAS REPORTED THE HEALTH CARE PROFESSIONAL REPORTED EVENT TO BFARM DIRECTLY: IT WAS REPORTED A FRACTURE OF FEMORAL SLEEVE/STEM WITHOUT TRAUMA OCCURRED POST-OPERATIVELY WHILE PATIENT WAS WALKING THE DOG. DOI: (B)(6) 2020. DOR: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693025 ↗
• InjuryJul 7, 2025Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. UPON EXPLANT, IT WAS REALIZED THE STEM AND SLEEVE JUNCTION WAS BROKEN. SURGEON REPORTED A FALL PRIOR TO REPORTS OF INSTABILITY. THERE WAS LOOSENING OF SLEEVE AND SROM FEMUR AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 22423884 ↗
• InjurySep 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  KNEE PROSTHESIS WHICH HAD BEEN PLACED ON (B)(6) 2022. AUGUST 2022: SECONDARY PROSTHETIC DISPLACEMENT WITH ROTATIONAL DISORDER -> EXTERNAL HYPER-ROTATION OF THE LOWER LIMB SECONDARY TO A PROSTHETIC ROTATIONAL DISORDER OCCURRING AT THE LPS PROSTHETIC METAPHYSIS/SLEEVE JUNCTION CEMENTED IN THE FEMUR. HYPER EXTERNAL ROTATION OF THE RIGHT LOWER LIMB DURING FLEXION RISK OF MICROMOBILITY OF A METAL-METAL COUPLE RETURN TO THE OPERATING ROOM ARTHROTOMY FOR REPLACEMENT OF THE DEFECTIVE PART.

  Patient problems: Insufficient Information

  MAUDE report 15410771 ↗
• MalfunctionAug 24, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SLEEVE WAS DIFFICULT TO ASSEMBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281966 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, PAIN, SWELLING, SYNOVITIS, REMOVAL OF FIBROUS TISSUE, AND TIBIAL COMPONENT LOOSENING. THE SURGEON HAD TO PERFORM A CORONAL PLANE OSTEOTOMY OF THE DISTAL FEMUR TO REMOVE THE WELL-FIXED FEMORAL COMPONENTS. THERE WAS NOTED TO BE REMOVAL OF CERCLAGE WIRES ON THE FEMUR THAT WERE PLACED PRIOR FOR AN UNKNOWN REASON ON AN UNKNOWN DATE. IT IS UNKNOWN IF THE WIRES WERE PREVIOUSLY PLACED DUE TO A COMPLICATION OR TO PREVENT ANY ISSUES.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 12862962 ↗
• InjuryNov 3, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO FEMUR WAS USED. THIS IS AN UNCEMENTED DEVICE, HOWEVER CEMENT IS UTILIZED TO COAT THE SPACER FOR THE PURPOSE OF ANTIBIOTIC DELIVERY. BOTH SLEEVES SUBSIDED FROM THE ORIGINAL POSITION THEY WERE PLACED CONSIDERING THEIR POSITION ON X-RAY, HOWEVER IT WAS THE FEMORAL SIDE SLEEVE WAS MOVING AT THE TIME OF SURGERY.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 12749944 ↗
• InjuryNov 3, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO FEMUR WAS USED. THIS IS AN UNCEMENTED DEVICE, HOWEVER CEMENT IS UTILIZED TO COAT THE SPACER FOR THE PURPOSE OF ANTIBIOTIC DELIVERY. BOTH SLEEVES SUBSIDED FROM THE ORIGINAL POSITION THEY WERE PLACED CONSIDERING THEIR POSITION ON X-RAY, HOWEVER IT WAS THE FEMORAL SIDE SLEEVE WAS MOVING AT THE TIME OF SURGERY.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 12749941 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014 THE PATIENT UNDERWENT A MEDIAL UNICOMPARTMENTAL TOTAL KNEE TO ADDRESS THE PREOPERATIVE DIAGNOSIS OF MEDIAL COMPARTMENT OSTEOARTHRITIS, RIGHT KNEE. NO COMPLICATIONS NOTED. MEDICAL RECORDS FROM (B)(6) 2019 NOTED THAT SINCE THE REVISION ON (B)(6) 2016, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING, EFFUSION, AND HAS HAD AN ASPIRATION PERFORMED. SURGEON NOTED A CONCERN FOR LOOSENING OF COMPONENTS, AS WELL AS OSTEOLYSIS VERSUS POSSIBLE INFECTION. RADIOGRAPHS WERE REPORTED TO SHOW POSSIBLE LOOSENING. AT THE TIME OF THIS REVIEW, THERE WERE NO REVISION INFORMATION.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10514692 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). ASSOCIATED STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE FEMORAL FRACTURE AND TIBIAL FRACTURES EVENT IS SERIOUS AND IS CONSIDERED MODERATE IN SEVERITY. EVENT IS RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2018. DOE: (B)(6) 2018 (RIGHT KNEE). OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8239382 ↗