PLUS UNI STEM UNI.STEM W.SLEEVE 2

Additional Manufacturer Narrative

SECTION D4 WAS UPDATED. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

H11: CORRECTED INFORMATION IN D1, AND D4.

Additional Manufacturer Narrative

INTERNAL REFERENCE NUMBER: (B)(4). INITIAL 30-DAY MDR.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNCLEAR ADVERSE EVENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE ECO MODULAR STEM WAS EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

Additional Manufacturer Narrative

SECTION H10: IT WAS REPORTED THAT, AFTER A TOTAL HIP REPLACEMENT SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNCLEAR ADVERSE EVENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON 09-JAN-2023, IN WHICH THE ECO MODULAR STEM WAS EXPLANTED. THE DEVICE INTENDED FOR USE IN TREATMENT WAS NOT RETURNED FOR INVESTIGATION, HOWEVER, A VISUAL INSPECTION WAS PERFORMED BASED ON A PICTURE PROVIDED BY THE COMPLAINANT. THE COMPLAINT IMPLANT IS IN GOOD GENERAL STATE AND SHOWS SOME SIGNS OF OSSEOINTEGRATION, NO PARTS ARE BROKEN OR MISSED. NO BATCH NUMBER WAS COMMUNICATED SO THE DOCUMENT HISTORY REVIEW WAS NOT POSSIBLE. DUE TO INSUFFICIENT INFORMATION IT IS NOT POSSIBLE TO PERFORM A REVIEW OF PAST CORRECTIVE ACTIONS. AS THE BATCH NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO PERFORM A COMPLAINT HISTORY REVIEW AT BATCH LEVEL, AND THE COMPLAINT HISTORY REVIEW BASED ON THE PRODUCT NUMBER REVEALED NO ADDITIONAL SIMILAR COMPLAINTS FOR THE PREVIOUS 12 MONTHS. THE RISK MANAGEMENT ASSESSMENT VERIFIES THAT THE OVERALL RISK LEVEL REMAINS LOW FOR THE DEVICE IN THE CONTEXT OF THE INDICATED FAILURE MODE. INSUFFICIENT INFORMATION WAS MADE AVAILABLE TO DETERMINE THE REVISION OF THE INSTRUCTIONS FOR USE APPLICABLE TO THE DEVICE AT THE TIME OF MANUFACTURING. DUE TO INSUFFICIENT INFORMATION ON THE REPORTED EVENT, IT IS NOT POSSIBLE TO PERFORM A PRECISE REVISION OF THE CURRENT INSTRUCTIONS FOR USE, HOWEVER, THE CURRENT INSTRUCTIONS FOR USE LISTS SEVERAL ¿POTENTIAL ADVERSE DEVICE EFFECTS¿ FROM A HIP ARTHROPLASTY. NO CLINICALLY SUFFICIENT DATA WAS PROVIDED TO PERFORM A MEDICAL INVESTIGATION. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO INVESTIGATE WHETHER THE REPORTED DEVICE MET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. THE PERFORMED INVESTIGATION DO NOT LEAD TO AN ACCURATELY DETERMINED CAUSE. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO NEED FOR FURTHER ACTIONS BECAUSE OF THE LIMITED INFORMATION PROVIDED. NEVERTHELESS, SMITH + NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THIS COMPLAINT WILL BE REOPENED SHOULD ADDITIONAL INFORMATION OR THE DEVICE BE RECEIVED. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).