TRIDENT II TRITANIUM CLUSTER50D

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED: LEFT-HIP-REVISION PERFORMED BY DR. TODAY. PT. PRESENTED WITH A DISLOCATED LEFT-HIP FROM A STUMBLE AND FALL, FOLLOWING A LEFT-THA (MDM DISLOCATED FROM THE SHELL). DR. OPTED TO PERFORM AN OPEN-REDUCTION AND REVISION OF THE BIOLOX HEAD AND X3 MDM COMPONENTS, "TO ADD MORE STABILITY."

Additional Manufacturer Narrative

REPORTED EVENT: AN EVENT REGARDING DISASSOCIATION 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 REMAINS IMPLANTED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE REPORTED DEVICE WAS MANUFACTURED WITH NO REPORTED RELEVANT DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE MDM LINER FROM THE SHELL. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.