TRIDENT HEMISPHERICAL MULTI

Additional Manufacturer Narrative

AN EVENT REGARDING ABNORMAL ION LEVEL INVOLVING A TRIDENT SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE INVALID. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE INVALID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE REVISION OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

Description of Event or Problem

AS PER MEDWATCH REPORTS MW5188325, MW5188326, MW5188327, MW5188328, MW5188329, MW5188330, MW5188331, MW5188332: REPORTER STATES SHE HAD A COMPLETE HIP REVISION ON (B)(6) 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 EXPERIENCED DIFFICULTY WALKING. REPORTER HAD THE INITIAL IMPLANT ON (B)(6) 2012 WITH DR. (B)(6) 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 SUSPECTS IT MAY BE DUE TO HEAVY METALS IN BODY. REPORTER STATES THAT SHE HAS SEEN RECALLS ON THESE TYPE OF DEVICES.