BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 1983393 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01237
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    DEPUY INTL LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: PATIENT WAS REVISED TO ADDRESS CHRONIC PAIN AND UNEXPECTED POSITIVE/ABNORMAL FINDINGS ON LAB AND IMAGING PRE-OP. OSTEOLYSIS WAS ALSO REPORTED. DOI (B)(6) 2006 - DOR (B)(6) 2011 (LEFT HIP). UPDATE (B)(4) 2011 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE (B)(4) 2011 - MEDICAL RECORDS RECEIVED BY (B)(4) ON (B)(6) 2011, FORWARDED TO CUSTOMER QUALITY ON (B)(4) 2011. THE REVISION OPERATIVE REPORT INDICATED HIP PAIN WITH FLUID AROUND THE HIP. ADDITIONALLY IT WAS NOTED THAT THERE WAS FRETTING AT THE JUNCTION OF THE FEMORAL HEAD MORSE TAPER AND THE SROM NECK MORSE TAPER. THE COMPLAINT WAS REOPENED TO ADD THE ADAPTER SLEEVE AND STEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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 WAS REVISED TO ADDRESS CHRONIC PAIN AND UNEXPECTED POSITIVE/ABNORMAL FINDINGS ON LAB AND IMAGING PRE-OP. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 87KWA KWA DEPUY INTL LTD NA 2192251

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention