UNKN ANTHOLOGY HIP IMPL

Additional Manufacturer Narrative

H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE ADVERSE EVENT WAS LIKELY PROCEDURE-RELATED, AND THE DEVICE HAD NO INFLUENCE ON THE EVENT. THE INFECTION IS HIGHLY LIKELY OF AN EXOGENOUS NATURE. SEROMA AND INFECTION ARE KNOWN RISKS OF ANY SURGERY AND CAN BE ADVERSE RESULTS OF THE PROCEDURE. THERE IS NO EVIDENCE THAT THE RECURRING SEROMA AND/OR THE JOINT INFECTION IS ASSOCIATED WITH THE IMPLANT. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR TOTAL HIP SYSTEMS REVEALED THAT INFECTION, BOTH EARLY, POST-OPERATIVE SUPERFICIAL AND EARLY, POST-OPERATIVE DEEP WOUND INFECTION AND LATE PERIPROSTHETIC INFECTION HAS BEEN IDENTIFIED AS A POTENTIAL COMPLICATION ASSOCIATED WITH TOTAL HIP ARTHROPLASTY SURGERY, PRIMARY OR REVISION. IT IS ADVISED IN POST OPERATIVE WARNINGS AND PRECAUTIONS FOR THE PATIENT TO REPORT ANY SWELLING AS THEY MAY INDICATE POSITION CHANGES IN THE COMPONENTS WHICH MAY COMPROMISE THE DURABILITY OF THE IMPLANTS. DEVICE SPECIFIC IDENTIFIERS WERE NOT PROVIDED. THEREFORE, AN EVALUATION OF THE MANUFACTURING RECORDS, COMPLAINT HISTORY REVIEW, RISK MANAGEMENT FILE, PRIOR ACTIONS AND STERILIZATION REVIEW COULD NOT BE PERFORMED. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE LOSS OF STERILITY DURING PROCEDURE, POST-OPERATIVE HEALING ISSUE, INJURY, PATIENT CONDITION AND/OR MEDICAL HISTORY. 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 THE DEVICE OR 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.

Additional Manufacturer Narrative

INTERNAL 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 A PATIENT UNDERWENT A THIRD REVISION SURGERY ON (B)(6) 2023 DUE TO SEROMA AND INFECTION. THE PATIENT UNDERWENT A RIGHT HIP WASHOUT WITH EXPLANT AND PLACEMENT OF A SPACER. PRIMARY RIGHT BHR PROCEDURE OCCURRED ON (B)(6) 2007.