BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR CUP HAP SIZE 52/58

    MDR report key: 10260852 · Received July 10, 2020

    Report

    Report Number
    3005975929-2020-00234
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    April 23, 2015
    Report Date
    August 6, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THIS COMPLAINT IS A DUPLICATE OF THE REPORT 3005975929-2018-00350 THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD THE PREVIOUS CORRECTION 3005975929-2020-00234-1. DUE TO A MISTAKE ON THE RECORD THE WRONG THE HIP WAS MARKED AS A DUPLICATE WHICH IS NOT. ON THIS REPORT A RIGHT HIP REVISION SURGERY DUE TO PROGRESSIVE METAL BEARING WEAR, INCREASING COBALT AND CHROMIUM LEVELS THAT TOOK PLACE ON (B)(6) 2015. THIS EVENT WAS UNREGISTERED UNTIL THIS RECORD WAS REPORTED. THIS EVENT IS A NEW EVENT THAT IS DIFFERENT FROM THE CORRECTION MDR SENT WITH THE CONSECUTIVE RECORD 3005975929-2018-00350-1. THERE HAS BEEN NO CHANGES ON THE INITIAL INFORMATION ALREADY INPUT FOR THIS (B)(4) (3005975929-2020-00234).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED. AS OF TODAY, THE IMPLANTED DEVICES, ALL OF WHICH WERE USED IN TREATMENT, AND ADDITIONAL INFORMATION HAVE BEEN REQUESTED FOR THIS COMPLAINT BUT HAVE NOT BECOME AVAILABLE. A REVIEW OF THE COMPLAINT HISTORY FOR THE BHR CUP AND BHR HEAD WAS PERFORMED USING BATCH NUMBERS IN SEARCH OF SIMILAR RECURRING REPORTS FOR THE PRODUCTS DURING THEIR LIFETIMES. SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED FOR THE BHR CUP AND BHR HEAD. THIS WILL CONTINUE TO BE MONITORED. IN THE ABSENCE OF THE ACTUAL DEVICES, THE PRODUCTION RECORDS WERE REVIEWED FOR THE DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. THE BHR CUP INVOLVED MET MANUFACTURING SPECIFICATIONS AT THE TIME OF PRODUCTION. NON-CONFORMANCE WAS IDENTIFIED FOR THE CASTINGS INSPECTION PROCEDURE PAPERWORK FOR THE BHR HEAD. HOWEVER, ALL SUPPORTING DOCUMENTS CONFIRM THAT THIS WAS AN ACCEPTABLE PRODUCT WHEN RELEASED. REVIEW OF THE PRODUCT IFU FOUND ADEQUATE WARNINGS AND PRECAUTIONS IN RELATION TO THE ALLEGED FAILURE MODES. A RISK MANAGEMENT REVIEW WAS PERFORMED. NO ADDITIONAL RISKS WERE IDENTIFIED AS RESULT OF THE REPORTED EVENT. SMITH AND NEPHEW HAS NOT RECEIVED THE DEVICE/ADEQUATE MATERIALS TO FULLY EVALUATE THE COMPLAINT, BUT IF ADDITIONAL CLINICALLY RELEVANT MATERIALS ARE LATER RECEIVED, THEN THE CASE MAY BE RE-OPENED FOR FURTHER EVALUATION. 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 THE PATIENT UNDERWENT A RIGHT HIP REVISION SURGERY DUE TO PROGRESSIVE METAL BEARING WEAR, INCREASING COBALT AND CHROMIUM LEVELS. THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722324 ACETABULAR CUP HAP SIZE 52/58 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 13BW12307

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R