BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN BIRMINGHAM HIP IMPL

    MDR report key: 25062829 · Received May 3, 2026

    Report

    Report Number
    3005975929-2026-00012
    Event Type
    Injury
    Date Received
    May 3, 2026
    Date of Event
    July 28, 2025
    Report Date
    May 2, 2026
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    MBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    <P STYLE="TEXT-ALIGN: JUSTIFY;">THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE IRREGULAR IMPLANT INTERACTION, WEAR, ABNORMAL MOTION OVER TIME OR PATIENT CONDITION. & NBSP; 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. </P>.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER UNDERGOING A METAL-ON-METAL HIP REPLACEMENT IN 2003, THE BIRMINGHAM HIP REPLACEMENT FELL APART IN 2018. A REVISION SURGERY WAS PERFORMED TO ADDRESS THIS EVENT, AND INTRAOPERATIVELY NECROSIS WAS VISIBLE IN THE PATIENT'S MUSCLES AND BONES. THE PATIENT HAD AN INFECTION AND HIGH METAL IONS (124 NMOL/L CO) IN HER BODY. AFTER SURGERY, THE PATIENT HAD PRESENTED JAUNDICE AND LIVER PROBLEMS AND HAD TO BE RUSHED TO EMERGENCY AS IT CAUSED CIRRHOSIS. A SCAN WAS PERFORMED AND EXPOSED METALLIC PARTICLES FOUND IN HER ABDOMEN, AROUND THE LIVER. THE PATIENT REQUIRES A CRUTCH AND WEARS A LEG BRACE BECAUSE ONE LEG IS TOO WEAK AND BADLY WARPED. SHE ALSO HAD PRESENTED TREMORS, WHICH IS ONGOING. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367752 UNKN BIRMINGHAM HIP IMPL PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS MBL SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| H