SPEC EF PRIM HO 12/14 SZ 1

Additional Manufacturer Narrative

INTERNAL REFERENCE: (B)(4) RESULTS OF INVESTIGATION: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED LOOSENING OF THE STEM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) SPEC EF PRIM HO 12/14 SZ 1, ONE (1) OXINIUM FEM HD 12/14 32MM +0, AND ONE (1) R3 20 DEG XLPE ACET LNR 32MM X 50MM WERE EXPLANTED AND REPLACED BY COMPETITOR DEVICES. DURING THE REVISION SURGERY IT WAS ALSO NOTICED THAT THE FEMORAL HEAD SHOWED CONSIDERABLE SIGNS OF WEAR, PRESUMABLY OCCURRING SUBSEQUENT TO THE STEM LOOSENING. IT APPEARS THAT THE OXIDISED LAYER HAD BEEN SCRAPED/WORN OFF. THE PATIENT HAS DISPLAYED SIGNS OF METALLOSIS. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.