UNKNOWN SIMPLICITI HEAD

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PROVIDED MEDICAL IMAGING WAS REVIEWED BY A STRYKER HCP AND REVEALED THE FOLLOWING FINDINGS: THERE SEEMS TO BE SOME EROSION OF THE NATIVE GLENOID AND SUBCHONDRAL CYSTS. WITH THIS LITTLE INFORMATION WE CANNOT DRAW ANY DEFINITIVE CONCLUSIONS AS TO WHAT THE REASON FOR THE INTENDED REVISION SURGERY WAS. SUFFICIENT (RADIOLOGICAL AND CLINICAL) INFORMATION MUST BE PROVIDED TO ENABLE A MEANINGFUL CLINICAL ASSESSMENT AND TO IDENTIFY POSSIBLE CAUSES OF FAILURE. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING WAS NOT POSSIBLE BECAUSE THE CATALOG NUMBER AND LOT NUMBER WERE NOT COMMUNICATED. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE CATALOG NUMBER AND LOT NUMBER WERE NOT COMMUNICATED. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

A REVISION SURGERY WAS PERFORMED USING THE BLUEPRINT PLANNING FEATURE, THE REASON FOR THE REVISION WAS NOT PROVIDED.

Additional Manufacturer Narrative

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

Description of Event or Problem

A REVISION SURGERY WAS PERFORMED USING THE BLUEPRINT PLANNING FEATURE, THE REASON FOR THE REVISION WAS NOT PROVIDED.