TORNIER SIMPLICITI NUCLEUS SIZE 2

Description of Event or Problem

PATIENT UNDERWENT LEFT PRIMARY ANATOMIC SHOULDER REPLACEMENT FOR PRIMARY IMPLANTS. OVER RECENT MONTHS PATIENT HAS BEEN COMPLAINING OF INCREASING PAIN AND INSTABILITY IN THIS SHOULDER JOINT, SUSPECTED ROTATOR CUFF FAILURE. DECISION MADE INTRA-OPERATIVELY TO REMOVE ALL PRIMARY IMPLANTS, AND CONVERT THIS PROSTHETIC JOINT TO A REVERSE SHOULDER REPLACEMENT. BOTH THE TORNIER SIMPLICITI HUMERAL COMPONENTS, AND THE PERFORM PEGGED GLENOID COMPONENT. NEGLIGIBLE BONE WAS LOST DURING THIS PART OF THE SURGERY. THE REVISION COMPONENTS IMPLANTED WERE FROM COMPETITOR (ENOVIS / DJO).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION WAS AVAILABLE. THE AVAILABLE PICTURE INDICATES BROKEN COMPONENT BUT IS NOT SUFFICIENT TO PERFORM THE DETAILED INSPECTION. 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 OR MANUFACTURING RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. 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 ANY FURTHER INFORMATION IS PROVIDED THE COMPLAINT REPORT WILL BE UPDATED.

Description of Event or Problem

PATIENT UNDERWENT LEFT PRIMARY ANATOMIC SHOULDER REPLACEMENT FOR PRIMARY IMPLANTS. OVER RECENT MONTHS PATIENT HAS BEEN COMPLAINING OF INCREASING PAIN AND INSTABILITY IN THIS SHOULDER JOINT, SUSPECTED ROTATOR CUFF FAILURE. DECISION MADE INTRA-OPERATIVELY TO REMOVE ALL PRIMARY IMPLANTS, AND CONVERT THIS PROSTHETIC JOINT TO A REVERSE SHOULDER REPLACEMENT. BOTH THE TORNIER SIMPLICITI HUMERAL COMPONENTS, AND THE PERFORM PEGGED GLENOID COMPONENT. NEGLIGIBLE BONE WAS LOST DURING THIS PART OF THE SURGERY. THE REVISION COMPONENTS IMPLANTED WERE FROM COMPETITOR (ENOVIS / DJO).