inforMED
MalfunctionJDK

KIT BONE CEMENT BIOPREP FEMORAL PREPARATION PLUG INSERTER CURETTE SUCTION STERIL

Received Jun 3, 2026 · Event occurred Oct 7, 2025

Report MW5188873 · MDR key 25373841

Device

Generic name

Prosthesis, Hip, Cement Restrictor

Catalog number

0206-710-000

Lot number

25135012

Patient

65 YR · Female

  • Insufficient Information

Narrative

Description of Event or Problem

WHILE PERFORMING A RIGHT REVERSE TOTAL SHOULDER. THE HUMERUS WAS THEN PREPARED WITH AN ENTRY REAMER FOR A SIZE 8 CEMENTED STEM. TRIALS WERE PERFORMED AND THERE WAS EXCELLENT STABILITY WITH A 3 POLY AND THE 8 STEM. THE CANAL WAS PREPARED BY DRYING THE CANAL THOROUGHLY AND THEN A CEMENT RESTRICTOR WAS PLACED. WHEN INSERTING THE CEMENT RESTRICTOR INTO THE CANAL, THE INSERTION DEVICE WAS NOT DISCONNECTING FROM THE CEMENT RESTRICTOR AS IT IS DESIGNED TO DO. MULTIPLE ATTEMPTS TO REMOVE THE CEMENT RESTRICTOR AND INSERTER FROM THE CANAL AND WERE UNSUCCESSFUL. THE PLASTIC INSERTION DEVICE FRACTURED UPON TRYING TO REMOVE IT FROM THE CANAL AND COULD NOT BE REMOVED BY ROTATING IT OFF THE CEMENT RESTRICTOR AND COULD NOT BE REMOVED BY ANY OTHER MEANS. IN ORDER TO REMOVE THE DEVICE FROM THE CANAL, THE INCISION AND DISSECTION WERE CARRIED DISTAL AND PROTECTING ALL SOFT TISSUES, AN OSTEOTOMY OF THE HUMEURS WAS PERFORMED WITH A SAW AND OSTEOTOMES. ULTIMATELY MAKING IT POSSIBLE TO REMOVE THE INSERTION DEVICE THAT WAS NOT FUNCTIONING PROPERLY AND FRACTURED WITHIN THE CANAL. THE DEVICE AND THE CEMENT RESTRICTOR WERE SUCCESSFULLY REMOVED IN THEIR ENTIRETY.