TRIDENT 10 DEG X3 INSERT 36F

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED: 2 OF 2: "I WAS WONDERING IF YOU CAN HELP US. WE RECENTLY HAVE 2 THR SURGICAL SITE INFECTIONS WHICH OCCURRED TO PATIENTS WE OPERATED ON A WEEK APART. BOTH OF THEM HAD VERY SIMILAR PRESENTATIONS IN THAT THE INFECTION WAS VERY AGGRESSIVE AND PATIENTS BECAME ACUTELY UNWELL. THEY HAVE GROWN THE SAME ORGANISM CALLED FUSOBACTERIUM NECROPHORUM WHICH IS QUITE UNUSUAL TO BE FOUND IN THRS. I HAVE LOOKED AT THE COMMONALITIES BETWEEN CASES AND THE ONLY THING I FOUND IN COMMON IS THE BATCH NUMBER FOR THE LINERS WHICH ARE: 723-10-36F; ACETABULAR LINER - POLY TRIDENT; F COMP 36MM (10 DEG) 9N2NTJ 05/01/2031. I MEAN THIS COULD BE A VERY RARE COINCIDENCE BUT WE WOULD JUST LIKE TO EXPLORE IF THERE HAS BEEN ANY RECALL OR ANYTHING THAT HAS BEEN FLAGGED UP IN TERMS OF CONTAMINATION ISSUES DURING THE MANUFACTURING PROCESS? "

Additional Manufacturer Narrative

REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAS BEEN 1 SIMILAR EVENT(S) FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.