BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR ACETABULAR CUP 58MM

    MDR report key: 7713278 · Received July 24, 2018

    Report

    Report Number
    3005975929-2018-00261
    Event Type
    Injury
    Date Received
    July 24, 2018
    Date of Event
    October 19, 2017
    Report Date
    October 24, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    UDI-DI
    03596010552310
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO INFECTION AND COMMINUTED INTERTROCHANTERIC FRACTURE ON BILATERAL PATIENT (LEFT SIDE C-0202522). DURING REVISION, THE BHR CUP, THE HEMI HEAD, MODULAR SLEEVE AN ANTHOLOGY STEM WERE REMOVED. AS OF TODAY, DEVICE RETURN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. IN THE ABSENCE OF THE ACTUAL DEVICES, THE PRODUCTION RECORDS WERE REVIEWED FOR THE DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. ALL THE RELEASED DEVICES INVOLVED MET MANUFACTURING SPECIFICATIONS AT THE TIME OF PRODUCTION. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. ACCORDING TO THE PROVIDED REVISION REPORT OF THE FIRST STAGE OF THE TWO-STAGE PROCEDURE, THE PATIENT HAD MULTIPLE WASHOUTS AND LONG-TERM ANTIBIOTICS DUE TO THE PROSTHETIC JOINT INFECTION AND EXTREME PAIN. PRE-OPERATIVELY BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS AND INFLAMMATORY MARKERS WERE SEVERELY ELEVATED. CORRESPONDING REPORTS WERE NOT PROVIDED. DURING THE REVISION, PURULENT FLUID, FROZEN SECTIONS WITH MANY POLYMORPHONUCLEAR NEUTROPHILS PER HIGH POWER FIELD, WELL FIXED COMPONENTS, A PERFORATION OF THE FEMORAL CORTEX, BONE LOSS AND A POSTERIOR WALL DEFECT WERE NOTED. REVIEW OF THE PROVIDED REPORTS OF THE IMPLANTATION, REVISION AND ONE WASHOUT DID NOT REVEAL RELEVANT FINDINGS THAT COULD EXPLAIN THE LATER REVISION. BASED ON THE RECEIVED INFORMATION THE IMPLANT COMPONENTS WERE REVISED DUE TO INFECTION. AN INFECTION DEVELOPING AROUND 7 YEARS POST IMPLANTATION IS A LATE INFECTION, WHICH NORMALLY HEMATOGENOUSLY ACQUIRED AND NOT THE RESULT OF AN INTRAOPERATIVE CONTAMINATION. THE MENTIONED PERFORATION PRESUMABLY REFERS TO THE REPORTED FRACTURE. WITHOUT RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE OR CONFIRM THE DETAILS SUPPLIED IN THIS COMPLAINT, HOWEVER BASED ON THE RECEIVED INFORMATION A POTENTIAL ROOT CAUSE FOR THIS REVISION IS A LATE INFECTION THAT IS NOT PRODUCT RELATED. IF THE PRODUCTS OR ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. NO PREVENTATIVE OR CORRECTIVE ACTION HAS BEEN INITIATED AS A RESULT OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED. DURING THE REVISION, THE HEMI HEAD, ANTHOLOGY STEM, ACETABULAR CUP & MODULAR SLEEVE WERE REMOVED. AS OF TODAY, DEVICE RETURN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. IN THE ABSENCE OF THE ACTUAL DEVICES, THE PRODUCTION RECORDS WERE REVIEWED FOR THE DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. ALL THE RELEASED DEVICES INVOLVED MET MANUFACTURING SPECIFICATIONS AT THE TIME OF PRODUCTION. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. PRE-OPERATIVE ASSESSMENT SHOWED BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS AND INFLAMMATORY MARKERS WERE SEVERELY ELEVATED. BASED ON THE RECEIVED INFORMATION THE IMPLANT COMPONENTS WERE REVISED DUE TO INFECTION. AN INFECTION DEVELOPING AROUND 7 YEARS POST IMPLANTATION IS A LATE INFECTION, WHICH NORMALLY HEMATOGENOUSLY ACQUIRED AND NOT THE RESULT OF AN INTRAOPERATIVE CONTAMINATION. THE MENTIONED PERFORATION PRESUMABLY REFERS TO THE REPORTED FRACTURE. REVIEW OF THE PROVIDED REPORTS OF THE IMPLANTATION, REVISION AND ONE WASHOUT DID NOT REVEAL RELEVANT FINDINGS THAT COULD EXPLAIN THE LATER REVISION. FURTHER, IT CANNOT BE CONCLUDED THAT THE REPORTED CLINICAL REACTIONS WERE ASSOCIATED WITH A MAL-PERFORMANCE OF THE IMPLANT. WITHOUT RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE OR CONFIRM THE DETAILS SUPPLIED IN THIS COMPLAINT, AND OUR INVESTIGATION REMAINS INCONCLUSIVE. IF THE PRODUCTS OR ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. NO PREVENTATIVE OR CORRECTIVE ACTION HAS BEEN INITIATED AS A RESULT OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT HIP REVISION WAS PERFORMED DUE TO INFECTION AND COMMINUTED INTERTROCHANTERIC FRACTURE. BILATERAL PATIENT WITH LEFT SIDE DEVICES STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556116 BHR ACETABULAR CUP 58MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD NA 09GW24234 03596010552310

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R FEMORAL STEM, # 71356109, LOT # 07FM20629| HEMI HEAD, # 74122552, LOT # 08GW18139| MODULAR SLEEVE, # 74222200, LOT # 09BW22217| FEMORAL STEM, # 71356109, LOT # 07FM20629| HEMI HEAD, # 74122552, LOT # 08GW18139| MODULAR SLEEVE, # 74222200, LOT # 09BW22217