ACC STD 265MM 11 CBL TRCH GRIP

Additional Manufacturer Narrative

H11: H2: ADDITIONAL INFORMATION: CONCOMITANT DEVICES ADDED TO THE REPORT.

Additional Manufacturer Narrative

H11: INTERNAL COMPLAINT REFERENCE (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION REPORTED THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE ABOUT A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT 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 CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR 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 THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, AND A FRACTURE ALONG WITH ONE (1) ACC STD 265MM 11 CBL TRCH GRIP. ACCORDING TO THE SURGEON, BONE UNION WAS ATTEMPTED WITH THE ACCORD GRIP, BUT THE FRACTURE DID NOT INTEGRATE. THIS ADVERSE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LINER AND INSERT WERE EXCHANGED TO OR3O DUAL MOBILITY LINER 38/50 AND OR3O DUAL MOBILITY XLPE INSERT 28/38 RESPECTIVELY, AND THE CUP WAS EXCHANGED TO R3 MULTI HOLE ACETABULAR SHELL 50MM. THE HEAD AND STEM WERE EXCHANGED TO COMPETITOR COMPONENTS. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.