PROFEMUR® MODULAR FEMORAL NECK

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

Description of Event or Problem

ALLEGEDLY, THE CUP WAS DISLOCATED DUE TO FALL DOWN OF THE PATIENT. JAPAN: (B)(6).

Additional Manufacturer Narrative

THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. BASED ON PROVIDED INFORMATION, THIS PATIENT DISLOCATED TWICE SHORTLY AFTER THE INDEX OPERATION. THE FIRST REVISION OCCURRED AFTER EXPERIENCING A FALL APPROXIMATELY 1 MONTH AFTER THE INDEX OPERATION. A SECOND REVISION TOOK PLACE ONE WEEK AFTER THE FIRST REVISION OPERATION DUE TO RECURRENT DISLOCATION, REFERENCE INCIDENT GROUP 25090007. PATIENT-SPECIFIC DETAILS, SUCH AS AGE, HEIGHT, WEIGHT, AND ACTIVITY LEVEL, ARE NOT KNOWN. MPO DID NOT RECEIVE ANY RADIOGRAPHIC IMAGES TO EVALUATE COMPONENT POSITIONING. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT MANUFACTURING LOTS INDICATES THAT THIS PART WAS MANUFACTURED TO SPECIFICATION. FURTHERMORE, MPO HAS NOT RECEIVED ANY COMPLAINT REPORTS INVOLVING THE SUBJECT MANUFACTURING LOTS. DURING THE FIRST REVISION OPERATION, A BIPOLAR SHELL OF THE SAME SIZE WAS IMPLANTED AS A REPLACEMENT, THE SHORT NEUTRAL MODULAR NECK WAS REPLACED WITH A LONG NEUTRAL MODULAR NECK, AND THE 26MM HEAD OF MEDIUM NECK LENGTH WAS REPLACED WITH A 26MM HEAD OF +3.5MM NECK LENGTH. BASED ON THE DEVICES THAT WERE IMPLANTED AND KNOWN CLINICAL HISTORY OF THIS PATIENT, THIS INFORMATION SUGGESTS THAT THE PATIENT MAY HAVE BEEN EXPERIENCING ISSUES WITH JOINT INSTABILITY. THE MICROPORT HIP SYSTEMS PACKAGE INSERT (150803-9) LISTS "DISLOCATION, MIGRATION AND/OR SUBLUXATION OF PROSTHETIC COMPONENTS FROM IMPROPER POSITIONING, TRAUMA, LOSS OF FIXATION AND/OR MUSCLE AND FIBROUS TISSUE LAXITY" AS POSSIBLE ADVERSE EFFECTS OF TOTAL HIP ARTHROPLASTY. MPO IS UNABLE TO PROVIDE ANY ADDITIONAL CONCLUSIONS REGARDING THIS EVENT. THERE WERE NOT ANY TRENDS IDENTIFIED FOR DISLOCATION INVOLVING THE SUBJECT DEVICES. MPO WILL CONTINUE TO MONITOR THROUGH COMPLAINT TRACKING. METHODS: DEVICE NOT RETURNED (4114). ANALYSIS OF PRODUCTION RECORDS (3331). TREND ANALYSIS (4110). RESULTS: NO FINDINGS AVAILABLE (3221). CONCLUSIONS: DEVICE MET SPECIFICATION. DEVICE WAS USED FOR TREATMENT. ADVERSE EVENT RELATED TO PATIENT CONDITION (50). CORRECT TYPE OF REPORTABLE EVENT: SERIOUS INJURY.