TRIDENT 0 DEG X3 INSERT 36E

Additional Manufacturer Narrative

AN EVENT REGARDING PATIENT FACTORS (WOUND DRAINAGE) INVOLVING A TRIDENT LINER 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. -DEVICE HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING WOUND DRAINAGE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE DETAILS, 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT # 6570-0-136; DELTA V-40 CERAMIC HEAD 36/0; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED: RIGHT-HIP "I&D AND POLY SWAP". PT. PRESENTED WITH A DRAINING SURGICAL WOUND, FOLLOWING A RIGHT MAKO-THA. DR. OPTED TO PERFORM AN I&D AND SWAPPED OUT THE "MODULAR COMPONENTS" OF THE HIP. THE 54MM TRIDENT 2 SHELL AND ACC2 STEM WERE LEFT IN-SITU. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.