BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*LINR LSER,10 DEG,22.225

    MDR report key: 3191309 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19928
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC
    Product Code
    KWA
    PMA / PMN Number
    PK924492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. REVIEW OF PROVIDED PATIENT X-RAYS FINDS THE HEAD IS NOT CENTERED IN THE CUP AND MAY HAVE SHIFTED SUPERIORLY. THIS COULD INDICATE POLY WEAR OF THE LINER AS MENTIONED IN THE COMPLAINT. THE PATIENT IS A REPORTED 62 Y/O MALE AT 107 KG AND 6 FEET TALL. CALCULATED BMI IS 32. THE PATIENT IS CONSIDERED OBESE. THE WEIGHT OF THE PATIENT EXCEEDS THE PROSTHESIS RECOMMENDATIONS. THERE ARE WARNINGS AGAINST IMPROPER PROSTHESIS SELECTION OR ALIGNMENT THAT TEND TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS INCLUDING EXCESSIVE PATIENT WEIGHT. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH PAIN. X-RAYS SHOWED POLYETHYLENE LINER WEAR. THE POLYETHYLENE LINER WAS WORN, WITH EVIDENCE OF POLYETHYLENE DISEASE (LYSIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291175 S-ROM*LINR LSER,10 DEG,22.225 ACETABULAR LINER KWA DEPUY ORTHOPAEDICS INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention