TORNIER PERFORM HUMERAL SYSTEM

Description of Event or Problem

PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6) JOINT RECONSTRUCTION NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6) JOINT RECONSTRUCTION PRODUCT. CLINICAL ADVERSE EVENT RECEIVED FOR SPEECH DISORDER. IMPLANTS WERE PLACED ON (B)(6) 2024. ON THE (B)(6) 2024 SHE SHOWED SPEECH DISORDER WITH INABILITY TO FORM WORDS FOR APPROXIMATELY 24 HOURS. THE PATIENT WAS TRANSFERRED ON THE SAME DAY TO THE STROKE UNIT OF THE PARTNER CLINIC, WHERE SHE UNDERWENT A COMPLEX STROKE TREATMENT. THE EVENT WAS ATTRIBUTED TO A DAMAGE OF THE PONS AND CONSIDERED LIFE-THREATENING DUE TO ITS PROXIMITY TO THE BREATHING CENTER. THE INVESTIGATOR ASSESSED THE SEVERITY OF THE EVENT AS MODERATE. ON THE (B)(6) 2024 THE PATIENT WAS DISCHARGED AS COMPLETELY RECOVERED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).