UNK EVOLVE PROLINE RADIAL HEAD

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

Description of Event or Problem

THE MANUFACTURER RECEIVED CLINICAL STUDY NAMED "RETROSPECTIVE DATA COLLECTION OF THE TREATMENT FOR TOTAL REPLACEMENT OF THE RADIAL HEAD WITH THE EVOLVE PROLINE IMPLANT " THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF EVOLVE PROLINE . THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES BETWEEN JANUARY 2010 TO JULY 2021. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: FOUR PATIENTS HAD HETEROTROPIC OSSIFICATION. ALL FOUR REQUIRE A SECONDARY OPERATION FOR THEIR AE. NONE OF THESE ADVERSE EVENT RESULT IN PERMANENT DISABILITY AND DEATH. ONE PATIENT REQUIRED A REMOVAL OF HARDWARE TO HELP TREAT THE HO AS THIS SUBJECT HAD INCREASED STIFFNESS AND LACK OF RANGE OF MOTION. THIS IS PATIENT 3 OF 4.