Kinematic 6475-3-933Recalls & reported problems
Howmedica Osteonics Corp. · Rotating Hinge Knee · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327046656), received between Oct 8, 2018 and Dec 6, 2023 — classified as 2 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Injury1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2023Fracture; Fracture
THIS PI IS FOR REVISION OF THE PATIENT'S LEFT KNEE. AS REPORTED: LEFT KNEE REVISION. ROTATING COMPONENT BROKEN & EXPLANTED. NEW COMPONENTS ATTEMPTED TO BE IMPLANTED HOWEVER DIAMETERS WERE TOO LARGE SO WOULD FIT. HOSPITAL DISPOSED OF EXPLANTS SO NOT AVAILABLE FOR RETURN. CAUSED DELAY OF 10 MINUTES ATTEMPTING TO MAKE NEW IMPLANTS FIT INTO PATIENT. NO SPECIFIC TRAUMA CAUSED TO PATIENT. ADDITIONAL INFORMATION REGARDING WASTED IMPLANTS: ALL 3 BUSHINGS WASTED/NOT IMPLANTED BECAUSE THEY TOO BIG OF A DIAMETER TO FIT IN FEMORAL COMPONENT ALREADY IN PATIENT. WE DID NOT HAVE THE CORRECT BUSHINGS DUE TO LACK OF IMPLANT DETAILS SPECIFIC TO PATIENT PRIOR TO THE SURGERY. THE REPRESENTATIVE WAS MISINFORMED BY THE SURGEON. SO THE SURGEON ATTEMPTED TO IMPLANT THE WRONG BUSHINGS WERE INADVERTENTLY & FOUND OUT INTRA-OPERATIVELY THEY WERE INCORRECT. THE SURGEON ELECTED TO IMPLANT ROTATING COMPONENT AXLE, & NEW BUMPER. THEY WERE ABLE TO FIT WITHOUT USING BUSHINGS.
Patient problems: Insufficient Information
MAUDE report 18279652 ↗InjuryOct 8, 2018Fracture; Fracture
ON (B)(6) 2018, THERE WAS NO PROBLEM WHEN VISITING OUTPATIENTS IN THE MORNING. MY KNEE SUDDENLY BECAME UNSTABLE FROM THE AFTERNOON AND WENT TO A NEARBY HOSPITAL. VISITED THE ORIGINAL HOSPITAL AGAIN AFTER OBSERVING ABOUT 3 MONTHS. ON SEPTEMBER 27, 2018, IT WAS CONFIRMED THAT REOPERATION WAS CARRIED OUT AND IT WAS BROKEN.
Patient problems: Injury
MAUDE report 7945675 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page