BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR ACETABULAR CUP

    MDR report key: 2852031 · Received November 30, 2012

    Report

    Report Number
    1818910-2012-24219
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 29, 2012
    Report Date
    October 14, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: PAIN; LARGE FLUID COLLECTION UNDER TENSION; CAPSULE WAS SIGNIFICANTLY FIBROSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT SOMETIME AFTER IMPLANTATION, THE PATIENT WAS ADVISED THAT HIS IMPLANT WAS FAILING AND THAT HE HAD HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN HIS BLOOD. ADDITIONALLY, THE LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED INJURIES OF A PERMANENT NATURE; ENDURED PAIN AND SUFFERING AND IS UNABLE TO ATTEND TO HIS NORMAL AFFAIRS AND DUTIES FOR AN INDEFINITE PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR ACETABULAR CUP ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R