BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SROM STEM

    MDR report key: 1923670 · Received December 9, 2010

    Report

    Report Number
    1818910-2010-08855
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 11, 2008
    Report Date
    November 9, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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.

    Description of Event or Problem · 1

    PT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PT DID NOT HAVE ASR, BUT WAS REVISED TO ADDRESS INSTABILITY RESULTING IN DISLOCATION. FURTHER REVIEW OF THE MEDICAL RECORDS REVEALED THAT THERE APPEARED TO BE 40-45 DEGREES OF ANTEVERSION PRESENT IN THE FEMORAL STEM. THE FEMORAL STEM WAS REMOVED AND PLACED IN THE CORRECT VERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SROM STEM TOTAL HIP REPLACEMENT KWY DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention