BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 3041759 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-01682
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    June 27, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    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. (B)(4).

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013-SALES REP REPORTED REVISION OF PATIENTS RIGHT HIP DUE TO UNKNOWN REASONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER DAMAGES INCLUDING BUT NOT LIMITED TO PAIN AND SUFFERING, FUTURE SURGERY AND MEDICAL TREATMENT, DISABILITY, DISFIGUREMENT. ***UPDATE*** (B)(4) 2011 PLAINTIFFS PRELIMINARY DISCLOSURE (PPD) FORM RECEIVED (B)(4) 2011. UPDATED PRODUCT INFO FOR CUP AND FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143799 ASR UNI FEMORAL IMPL SIZE 45 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2344578

    Patients

    Seq Age Sex Outcome Treatment
    1 Other