PROFEMUR® NECK A/R VAR/VAL 2 SHORT COBALT CHROME

Description of Event or Problem

ALLEGEDLY, REPORTER STATES SHE HAD COMPLETE HIP REVISION ON 2026 DUE TO HER PREVIOUS HIP IMPLANT LEAKING COBALT INTO HER BLOODSTREAM. REPORTER IS STILL RECOVERING FROM THE REVISION 5 WEEKS AGO AND SHE HAS HAD TROUBLE WALKING. REPORTER HAD THE INITIAL IMPLANT ON 2012 WITH DR. (B)(6) AT THE HOSPITAL. PT STARTED EXPERIENCING EXTREME FATIGUE, HEADACHES, COGNITIVE ISSUES, BODY ACHES, SHORTNESS OF BREATH AFTER MILD ACTIVITY AND JOINT PAIN FOR THE LAST COUPLE OF YEARS. WITHIN THE TIMEFRAME REPORTER ALSO EXPERIENCED CHRONIC FATIGUE SYNDROME. SHE HAD MULTIPLE TESTING DONE SUCH AS X-RAY AND MRI THAT WEREN'T CONCLUSIVE UNTIL SHE HAD A SPECIFIC MRI THAT SHOWED METALS IN BLOODSTREAM AND LAB WORK THAT SHOWED HEAVY METAL DAMAGE. SHE ALSO HAD HER GALLBLADDER REMOVED AND SUSPECTED IT MAY BE DUE TO HEAVY METALS IN BODY. REPORTER STATES THAT SHE HAS SEEN RECALLS ON THESE TYPES OF DEVICES. PT: 4847, 1816, 1849, 1880, 2551, 4836, 1924, 2687, 1868, 1931. DEVICE: 1261, 3023, 1354, 1212, 1131. HEALTH EFFECT - CLINICAL CODE(S): 1816: DYSPNEA, 1849: FATIGUE, 1868: FOREIGN BODY REACTION, 1880: HEADACHE, 1924: FAILURE OF IMPLANT, 1931: INFILTRATION INTO TISSUE, 2551: COGNITIVE CHANGES, 2687: FOREIGN BODY IN PATIENT, 4836: LIMB PAIN, 4847: HIGH METAL ION LEVELS. MEDICAL DEVICE PROBLEM CODE(S): 1131: CORRODED, 1212: ENTRAPMENT OF DEVICE, 1261: MATERIAL FRAGMENTATION, 1354: LEAK/SPLASH, 3023: THERAPEUTIC OR DIAGNOSTIC OUTPUT FAILURE. REF: MW5188325, MW5188329, MW5188327, MW5188328.

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.