R3 MULTI HOLE ACETABULAR SHELL 54MM

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H11: 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 ALTER THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT FOLLOWING A TOTAL HIP REPLACEMENT (THR) SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED LOOSENING OF ONE (1) R3 MULTI-HOLE ACETABULAR SHELL 54 MM IN JUN-2025. FURTHERMORE, IN (B)(6) 2026, ONE (1) POLARSTEM STEM LAT. TI/HA 2 NON-CEMENTED WAS ALSO FOUND TO BE LOOSE. AN INFECTION WAS SUSPECTED AND THEN CONFIRMED. THIS ADVERSE EVENT WAS SCHEDULED TO BE TREATED WITH A REVISION SURGERY ON (B)(6) 2026. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.