BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ROM

    MDR report key: 2120931 · Received May 30, 2011

    Report

    Report Number
    2120931
    Event Type
    Malfunction
    Date Received
    May 30, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 30, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TOTAL HIP ARTHROPLASTY WAS PERFORMED AT AN OUTSIDE HEALTHCARE FACILITY. POSTOPERATIVELY PT WAS NOTED TO HAVE SIGNIFICANT ABDUCTOR WEAKNESS. EVALUATION REVEALED PROBABLE INJURY TO THE SUPERIOR GLUTEAL NERVE. IN SPRING OF 2010 SHE UNDERWENT REMOVAL OF A SCREW FROM THE ACETABULUM IN HOPES THAT THIS MIGHT RELIEVE PRESSURE ON THE SUPERIOR GLUTEAL NERVE. POSTOPERATIVELY SHE DID NOT DEVELOP ANY ACTIVE ABDUCTION AND IN FACT HAD SEVERAL DISLOCATIONS IN EXTERNAL ROTATION.DOCTORS SUSPECTED THAT THIS IMPLIED THAT THE ABDUCTORS WERE NEITHER PROVIDING ACTIVE NOR EVEN PASSIVE RESISTANCE TO ADDUCTION AND THAT THE ANTERIOR CAPSULE HAD FAILED. SHE BEGAN TO EXPERIENCE SOME NOISE IN HER TOTAL HIP REPLACEMENT AND BECAUSE OF THIS, WE WERE SUSPICIOUS OF INCREASED WEAR. SHE DID NOT HAVE A MARKEDLY ELEVATED COBALT LEVEL, HOWEVER, SO WE DO NOT KNOW WHETHER THERE WAS ANY INCREASED WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM PROSTHESIS, HIP, FEMORAL HEAD LPH DEPUY ORTHOPAEDICS, INC. 136533000 2947708
    2 PINNACLE NEUTRAL PROSTHESIS, HIP, INSERT KWA DEPUY ORTHOPAEDICS, INC. 121887350 3028927

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR