BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)

    MDR report key: 11282400 · Received February 4, 2021

    Report

    Report Number
    3005975929-2021-00073
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    July 31, 2020
    Report Date
    February 23, 2021
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW, 1 HIP JOINT LAVAGE TREATED WITH ANTIBIOTIC THERAPY FOR A CASE OF INFECTION WAS REPORTED WHILE USING BHR COMPONENTS. THE IMPLANTED DEVICES WHICH WERE USED IN TREATMENT WERE NOT REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. AS NO DEVICE BATCH NUMBERS WERE PROVIDED FOR INVESTIGATION, A MANUFACTURING RECORD, COMPLAINT HISTORY AND DEVICE LABELLING / IFU REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED. A RISK MANAGEMENT REVIEW WAS PERFORMED. NO ADDITIONAL RISKS WERE IDENTIFIED AS RESULT OF THE REPORTED EVENT. NO MEDICAL RECORDS OR SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO REVISIONS WERE PERFORMED. SMITH AND NEPHEW HAS NOT RECEIVED ADEQUATE MATERIALS (OPERATIVE REPORTS) 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. OCCURRENCE DATE IS ACTUALLY UNKNOWN. 31-JUL-2020 WAS THE DATE THE LITERATURE PAPER WAS ACCEPTED FOR PUBLICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PIERRE MARTINOT ET AL. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 106 (2020) 1507-1510 ¿RETURN TO WORK AFTER HIP RESURFACING¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW ¿RETURN TO WORK AFTER HIP RESURFACING¿, 1 HIP JOINT LAVAGE TREATED WITH ANTIBIOTIC THERAPY FOR CASE OF INFECTION WAS REPORTED WHILE USING BHR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178357 UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE) PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R