EVOLVE HEAD 18MM

Additional Manufacturer Narrative

THE DEVICE REMAINS IMPLANTED IN THE PATIENT. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD A LOOSENING LINE ABOUT 10 MONTHS POST-OP. 2 YEARS POST-OP THE BONE RESORPTION SEEMS TO BE PROGRESSING, AND THERE IS A GAP VISIBLE BETWEEN THE OSTEOTOMY SURFACE AND THE STEM. THE PATIENT HAS NO COMPLAINTS AND IS UNDER OBSERVATION.

Additional Manufacturer Narrative

THE REPORTED EVENT COULD BE CONFIRMED SINCE X-RAY IMAGES WERE PROVIDED AND SHOWS LOOSENING OF THE IMPLANT. UPON FURTHER INVESTIGATION OF THE X-RAY IMAGES BY HEALTHCARE PROFESSIONALS THE FOLLOWING WAS OBSERVED: THERE IS A RADIAL HEAD REPLACEMENT WITH A REASONABLE POSITIONING VISIBLE ON THE X-RAY. TWO YEARS LATER A SIGNIFICANT RADIOLUCENCE AND PROTRUSION PROXIMALLY HAS OCCURRED. RADIOLOGICALLY LOOSENING SEEMS TO BE VISIBLE, HERE. CLINICALLY, HOWEVER, IT SEEMS AS IF THE PATIENT WOULD NOT HAVE ANY PROBLEMS AND THERE IS NO CLINICAL SIGN OF LOOSENING. THE BONE RESORPTION IS LIKELY DUE TO LOOSENING. THERE IS A SMALL CHANCE THAT THE IMPLANT HAS ADAPTED TO THE SURROUNDING ANATOMY AND WILL STAY STABLE IN THIS POSITION WITH FUTURE RADIOLOGICAL CONSOLIDATION. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. 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. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. THE INSTRUCTIONS FOR USE WERE REVIEWED AND STATES: IN ANY SURGICAL PROCEDURE, THE POTENTIAL FOR COMPLICATIONS EXISTS. THE RISKS AND COMPLICATIONS WITH THESE IMPLANTS INCLUDE LOOSENING OR DISLOCATION OF THE PROSTHESIS REQUIRING REVISION SURGERY AND BONE RESORPTION OR OVER-PRODUCTION. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. 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 THE PATIENT HAD A LOOSENING LINE ABOUT 10 MONTHS POST-OP. 2 YEARS POST-OP THE BONE RESORPTION SEEMS TO BE PROGRESSING, AND THERE IS A GAP VISIBLE BETWEEN THE OSTEOTOMY SURFACE AND THE STEM. THE PATIENT HAS NO COMPLAINTS AND IS UNDER OBSERVATION.