IFUSE IMPLANT SYSTEM
Received May 11, 2021 · Event occurred Apr 12, 2021
Report 3007700286-2021-00041 · MDR key 11809854
Device
Product problems
- Loss of Osseointegration
- Loss of Osseointegration
Patient
56 YR
- Arthralgia
- Arthralgia
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF CONFORMANCE AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS IMPLANT LATE LOOSENING. THE PATIENT'S LATER HIP REPLACEMENT MAY HAVE CONTRIBUTED TO THE POSSIBLE IMPLANT LOOSENING.
Description of Event or Problem
THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD GOOD SI JOINT RELIEF FOLLOWING THE INITIAL PROCEDURE, BUT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS AFTER HIP REPLACEMENT SURGERY. THE SURGEON DETERMINED POSSIBLE LOOSENING OF THE MIDDLE AND INFERIOR POSITIONED IMPLANTS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE, AND INSTALLED A NEW, WIDER, IMPLANT OF THE SAME TYPE IN THE EXPLANT VOID. THE EXPLANTED IMPLANT HAD VERY GOOD BONE ON-GROWTH. HE THEN ATTEMPTED TO REMOVE THE MIDDLE POSITIONED IMPLANT, BUT IT WAS ALSO SOLIDLY FIXED IN BONE AND WOULD NOT MOVE, SO HE LEFT IT IN PLACE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.