BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 3 HOLE HA CTD ACET SHELL 56MM

    MDR report key: 4103280 · Received September 19, 2014

    Report

    Report Number
    1020279-2014-00571
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICES WAS RETURNED AND EVALUATED. IT WAS NOTED IN THE VISUAL INSPECTION SOME SIGNIFICANT DAMAGE TO THE LINER (A CRACK RUNS FROM THE TOP EDGE TO THE CENTER OF THE INSIDE DIAMETER) AND TO THE OXINIUM HEAD (DEEP SCRATCHES FROM THE RADIUS TO THE FLAT ON THE BOTTOM OF THE OUTSIDE DIAMETER.) THE REVIEW OF THE COMPLAINT HISTORY SHOWS NO PRIOR COMPLAINTS FOR THE LISTED LOTS. A LAB ANALYSIS WAS COMPLETED ON THE RETURNED DEVICES AND THE RESULTS REVEALED IT IS NOT KNOWN IF THE DAMAGE TO THE DEVICES OCCURRED WHILE IMPLANTED OR DURING EXPLANTATION. BASED ON THE APPEARANCE OF THE DAMAGE, IT IS THEORIZED THAT IT IS DUE TO INSTRUMENT DAMAGE AT THE TIME OF EXPLANTATION. DUE TO THE DAMAGE TO THE ACETABULAR LINER, IT WAS NOT POSSIBLE TO ESTIMATE THE AMOUNT OF WEAR THAT OCCURRED IN THIS ACETABULAR LINER. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581723 R3 3 HOLE HA CTD ACET SHELL 56MM HIP IMPLANT JDH SMITH & NEPHEW, INC. 11HM11245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 71312373,71312412,71332540,71332520,71335756| 71343600