UNKNOWN SIMPLICITI HUMERAL HEAD

Description of Event or Problem

IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED DUE TO FALL TRAUMA. PATIENT EXPERIENCED IMPLANT PAIN AND SOME INSTABILITY. MIR CONFIRMED A TOTAL SUBSCAP RUPTURE.

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.

Additional Manufacturer Narrative

THE REPORTED EVENT COULD BE CONFIRMED, SINCE AN MRI IS A SENSITIVE TOOL FOR DIAGNOSING ROTATOR CUFF TENDON TEARS. SINCE X-RAYS WERE PROVIDED, THE OPINION OF THE MEDICAL EXPERT WAS SOUGHT AND STATED AS FOLLOWS: WE MAY CONSIDER THE REPORT AS CONFIRMED, GIVEN THAT MRI IS A SENSITIVE TOOL FOR DIAGNOSING ROTATOR CUFF TENDON TEARS. HOWEVER, WE DO NOT HAVE DIRECT ACCESS TO THE MRI TO VERIFY THIS OURSELVES. THE PATIENT'S PRIOR SURGERIES MAY HAVE AFFECTED THE INTEGRITY OF THE ROTATOR CUFF, AND THE REPORTED FALL IS THE MOST LIKELY CAUSE OF THE SUBSCAPULARIS TENDON RUPTURE AT THAT TIME. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A PATIENT CONDITION RELATED ISSUE. THE EVENT WAS CAUSED BY THE SUBSCAPULARIS TENDON RUPTURE. 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 DID NOT INDICATE ANY ABNORMALITIES. 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

IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED DUE TO FALL TRAUMA. PATIENT EXPERIENCED IMPLANT PAIN AND SOME INSTABILITY. MIR CONFIRMED A TOTAL SUBSCAP RUPTURE.