TORNIER SIMPLICITI NUCLEUS SIZE 3

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

AS REPORTED: "SUBJECT: (B)(4) SHOUT CLINICAL STUDY. DEEP INFECTION. PATIENT UNDERWENT A REVISION L TSA WITH EXCHANGE OF SIMPLICITY HEAD TO TORNIER STEM IMPLANT."

Additional Manufacturer Narrative

PLEASE NOTE CORRECTION TO D1 (PRODUCT LONG DESCRIPTION), D4 (CATALOG #, LOT #, AND GTIN). THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. MICROBIOLOGIST REVIEWED THE STERILIZATION PROCEDURES, ENVIRONMENTAL MONITORING BIOBURDEN DATA AND THE DHR AND NOTED THE SUBJECT DEVICE WAS PACKAGED ACCORDING TO ESTABLISHED DESIGN AND PROCESS SPECIFICATIONS AND WAS STERILIZED ACCORDING TO PROCEDURE. NO DEVIATION FOR A NONCONFORMANCE COULD BE FOUND. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED THE INVESTIGATION REPORT WILL BE REASSESSED.

Description of Event or Problem

AS REPORTED: "SUBJECT: (B)(6) CLINICAL STUDY. DEEP INFECTION. PATIENT UNDERWENT A REVISION L TSA WITH EXCHANGE OF SIMPLICISTIC HEAD TO TORNIER STEM IMPLANT."