BIOPRO PSL HIP STEM
Received Jun 30, 2020 · Event occurred Jun 25, 2020
Report 1832656-2020-00004 · MDR key 10214464
Device
Product problems
- Fracture
Patient
80 YR
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
ON 6/25/2020 BIOPRO WAS NOTIFIED OF A FAILED EXTRA SHORT HIP STEM. THE STEM WAS IMPLANTED ON (B)(6) 2009. AN ADDITIONAL PHONE CALL WAS HELD WITH THE SURGEON ON 6/29/2020 TO GATHER MORE INFORMATION. THE PATIENT WAS EXPERIENCING PAIN FOR QUITE A WHILE, BUT WAS WALKING. WHEN SHE EXPLAINED THE PAIN AN X-RAY WAS PERFORMED AND THE FRACTURE OF THE HIP STEM WAS EVIDENT. SHE INDICATED THAT 2 YEARS PREVIOUSLY SHE HAD SUFFERED A FALL. UPON REVIEW OF AN X-RAY TAKEN IN 2019 A HAIR LINE FRACTURE IN THE HIP STEM WAS EVIDENT, BUT NOT NOTED AT THE TIME OF THE X-RAY. IT IS UNKNOWN WHEN THE HIP STEM FAILED, BUT REMODELING OF THE BONE AROUND THE DISTAL END OF THE IMPLANT IS INDICATIVE OF THE IMPLANT MOVING WITHIN THE BONE FOR AN EXTENDED PERIOD OF TIME. ADDITIONALLY, WHEN THIS HIP WAS IMPLANTED IN 2009 THE SURGEON UTILIZED A TECHNIQUE WHICH RESULTED IN THE HIP STEM REMAINING SOMEWHAT MORE PROXIMAL, THE SURGEON HAS SINCE MODIFIED HIS IMPLANT TECHNIQUE. THE HIP WILL BE REMOVED AND WILL BE EXAMINED WHEN IT IS RETURNED.