IFUSE IMPLANT SYSTEM
Received Nov 11, 2020 · Event occurred Oct 19, 2020
Report 3007700286-2020-00114 · MDR key 10826612
Device
Product problems
- Inadequacy of Device Shape and/or Size
- Loss of Osseointegration
- Inadequacy of Device Shape and/or Size
- Loss of Osseointegration
Patient
30 YR
- Arthralgia
- Arthralgia
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU 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 POSSIBLY DUE TO THE PATIENT'S CONDITION.
Description of Event or Problem
THE PATIENT HAS SMALL SI JOINTS, OSTEOARTHRITIS AND HAD A PREVIOUS BILATERAL HIP OSTEOTOMY. THE PATIENT HAD STAGED SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT HAD TWO MONTHS OF SI JOINT PAIN RELIEF BUT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED POSSIBLE LOOSENING OF ONE OF THE LEFT SIDE IMPLANTS. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED ONE OF THE LEFT SIDE IMPLANTS AND REPLACED IT WITH AN IMPLANT OF THE SAME TYPE IN A NEW POSITION CLOSER TO THE INITIAL SUPERIOR POSITIONED IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.