SKELETAL DYNAMICS INC.

Description of Event or Problem

AN IMPLANTED ALIGN RADIAL HEAD WAS LOOSE, REQUIRING REVISION SURGERY.

Additional Manufacturer Narrative

THE INSTRUCTIONS FOR USE FOR THE ALIGN RADIAL HEAD SYSTEM STATES THE FOLLOWING: "THE LOCK SCREW PACKAGED WITH THE RADIAL HEAD MUST BE INSTALLED AND FULLY TIGHTENED TO FIX THE RADIAL HEAD TO THE RADIAL STEM. THE RADIAL HEAD PROSTHESIS IS DESIGNED TO BECOME A MONOBLOCK FOLLOWING FIXATION OF THE LOCK SCREW. IF THE LOCK SCREW IS NOT ATTACHED AND/OR FULLY SECURED, THE RADIAL HEAD MAY LOOSEN AND/OR DISCONNECT FROM THE RADIAL STEM, CAUSING SOFT TISSUE IRRITATION AND/OR DEVICE FAILURE." " IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT, OR FIXATION OF THE IMPLANTED COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS, WHICH MAY LEAD TO A SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." "MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE PROSTHESIS OR ANATOMICAL STRUCTURES." "SEEK MEDICAL HELP IMMEDIATELY IF IMPLANT MALFUNCTIONS." ALTHOUGH NO IMAGES FROM THE CASE WERE PROVIDED, THIS EVENT IS CONSISTENT WITH KNOWN RISKS ASSOCIATED WITH IMPROPER IMPLANTATION AS DESCRIBED IN THE INSTRUCTIONS FOR USE. METALLOSIS IS A KNOWN POTENTIAL OUTCOME ASSOCIATED WITH IMPLANT LOOSENING THAT CAN BE AVOIDED BY ADDRESSING A MALFUNCTION AS SOON AS IT OCCURS.