PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Description of Event or Problem

IT WAS FIRST REPORTED THAT THERE WAS A SLIDE-LOC REMOVAL CASE SCHEDULED FOR (B)(6) 2025. THE SURGEON'S PLAN IS TO ONLY REMOVE THE HEAD BUT SAID HE MAY GO AFTER THE STEM SO WE WILL NEED AN INSTRUMENT SET TO REMOVE. THIS IMPLANT WAS PUT IN BACK IN 2018 BY A DIFFERENT SURGEON BUT HAD RECENTLY DISSOCIATED. DUE TO ACUMED'S VOLUNTARY MEDICAL DEVICE REMOVAL AND MARKET DISCONTINUATION IN 2017, ON (B)(6) 2025, THE PRESIDENT OF ACUMED AS WELL AS THE VICE PRESIDENT OF QUALITY ASSURANCE & REGULATORY AFFAIRS PROVIDED SIGNED, SPECIAL APPROVAL TO DISTRIBUTE ONE FULL INSTRUMENT SET FOR THE SURGERY INDICATED, PER THE PLAN OF Z-2197-2017. THE REMOVAL SURGERY REPORTED THAT THE HEAD SLID RIGHT OUT, THEN USED BACK-SLAP TO REMOVE THE STEM.

Additional Manufacturer Narrative

TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE. RELATED REPORTS (INCLUDING THIS ONE) 3025141-2025-00590, 3025141-2025-00591, 3025141-2025-00592.