BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL SIMPLEX P RADIOOPAQUE BONE CEMENT

    MDR report key: 1132053 · Received August 21, 2008

    Report

    Report Number
    9610726-2008-00053
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 1, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED IN AN ARTICLE ("HYPERSENSITIVITY POLYMETHYLMETHACRYLATE FOLLOWING SHOULDER HEMIARTHROPLASTY" IN THE ORTHO SUPERSITE, ORTHOPEDICS 2008; 31:708 2008. A WOMAN SUSTAINED A CLOSED FRACTURE DISLOCATION OF THE RIGHT PROXIMAL HUMERUS FOLLOWING A FALL ONTO AN OUTSTRETCHED HAD. A SHOULDER PROSTHESIS WAS USED FOR THE RECONSTRUCTION. SURGICAL SIMPLEX P RADIOOPAQUE BONE CEMENT HOWMEDICA, INC. WAS PLACED USING A SYRINGE AND SIMPLE FINGER PACKING CEMENTING TECHNIQUE. FOUR MONTHS POSTOPERATIVELY, THE PT WAS NOTED TO HAVE WEAKNESS AND PAIN. DUE TO POSSIBLE INFECTION A SHOULDER JOINT ASPIRATION WAS PERFORMED. PT CONTINUED TO HAVE PAIN, PERSISTENT ERYTHEMA AND INFLAMMATION. ULTIMATELY, AT NEARLY 3 YEARS AFTER HER SURGERY, COMPLETE REMOVAL OF THE HARDWARE AND CEMENT WAS PERFORMED. THIS SIGNIFICANTLY REDUCED HER PAIN AND YIELDED COMPLETE RESOLUTION OF HER ERYTHEMA. DUE TO ONGOING MEDICAL CONCERNS, INCLUDING PROGRESSIVE AMYOTROPHIC LATERAL SCLEROSIS (LOU GEHRIG'S DISEASE), FURTHER SURGERY HAS BEEN AVOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SIMPLEX P RADIOOPAQUE BONE CEMENT BONE CEMENT LOD STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other