AMISTEM C FEMORAL STEMS

Additional Manufacturer Narrative

CLINICAL EVALUATION REVISION OF PRIMARY HYBRID THA. DETAILS OF PRIMARY SURGERY, INCLUDING DATE, ARE NOT KNOWN. THE CEMENTED STEM IS POSITIONED IN VALGUS, AND THE CEMENT MANTLE IS NONHOMOGENEOUS AND RATHER THICK. THE MOST LIKELY CAUSE FOR LOOSENING OF THE STEM IS TECHNICAL ERROR AT PRIMARY SURGERY. OF COURSE, THERE MAY HAVE BEEN PROBLEMS DURING THE OPERATION, OR PROBLEMS SPECIFIC TO THE PATIENT, THAT ARE NOT REPORTED AND THEREFORE CANNOT BE CONSIDERED IN THIS ANALYSIS. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE, IT IS POSSIBLE THAT THE STEM LOOSENING IS RELATED TO A FACTORS ASSOCIATED WITH THE PRIMARY SURGERY APPLICATION, CONSIDERING THAT THE CEMENTED STEM WAS POSITIONED IN VALGUS AND THE CEMENT MANTLE WAS DESCRIBED AS NONHOMOGENEOUS AND RELATIVELY THICK. HOWEVER, THERE IS INSUFFICIENT INFORMATION AVAILABLE REGARDING THE PRIMARY SURGERY AND NO PRODUCT DETAILS COULD BE PROVIDED. THEREFORE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED FOR THIS CASE.

Description of Event or Problem

REVISION SURGERY DUE TO STEM LOOSENING. THERE IS NO AVAILABLE INFORMATION ABOUT THE IMPLANTS INVOLVED IN THE PRIMARY SURGERY. THE SURGEON REVISED THE STEM AND HEAD TO A COMPETITOR STEM AND HEAD, AND REVISED THE LINER TO A D 28/DMC DOUBLE MOBILITY LINER ALONG WITH A DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.