UNKN MEMPHIS RECON HIP INSTR

Additional Manufacturer Narrative

INTERNAL REFERENCE NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, DURING THE FINAL TRIAL REDUCTION IN A HIP REPLACEMENT SURGERY, A 32MM +0 HEAD TRIAL CAME OFF AND GOT STUCK TO SOFT TISSUE AROUND THE RECTUS MUSCLE CLOSE TO THE FEMORAL ARTERY. THE SURGEONS TRIED TO RETRIEVE THE TRIAL, BUT DECIDED TO LEAVE IT IN THE PATIENT. IT WAS ACKNOWLEDGED THAT THE INCIDENT WAS A SURGEON ERROR. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

Additional Manufacturer Narrative

H3, H6: GIVEN THE NATURE OF THE ALLEGED INCIDENT, THE DEVICE COULD NOT BE RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT THE ADVERSE EVENT WAS LIKELY CAUSED PARTIALLY OR WHOLLY BY THE USER. THE PATIENT IMPACT IS DETERMINED TO BE ADDITIONAL SURGICAL TIME <60 MINUTES. THE TRIAL HEADS ARE NOT APPROVED FOR LONG-TERM INTERNAL TISSUE EXPOSURE AND LONG-TERM IMPLANTATION DATA IS NOT AVAILABLE. THE PATIENT IMPACT BEYOND POSSIBLE MICRO-MOTION AND/OR MIGRATION, AND LOCAL IRRITATION/DISCOMFORT CANNOT BE DETERMINED. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR TOTAL HIP SYSTEMS REVEALED IN THE WARNINGS AND PRECAUTIONS SECTION THAT TRIAL INSTRUMENTATION MAY BE PROVIDED FOR THE INTRAOPERATIVE ASSESSMENT OF THE FINAL IMPLANT FIT. ALSO, IT SPECIFIES TO NOT IMPLANT TRIAL COMPONENTS. DEVICE SPECIFIC IDENTIFIERS WERE NOT PROVIDED. THEREFORE, AN EVALUATION OF THE MANUFACTURING RECORDS, COMPLAINT HISTORY REVIEW, RISK MANAGEMENT FILE AND PRIOR ACTIONS COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE UNSATISFACTORY EXPERIENCE COULD BE CONFIRMED. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.