BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 2121187 · Received June 1, 2011

    Report

    Report Number
    1818910-2011-09397
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    November 16, 2010
    Report Date
    May 2, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE: ON (B)(6) 2009, PATIENT HAD THE ASR XL SYSTEM IMPLANTED INTO HER RIGHT HIP. AFTER HAVING THE ASR IMPLANTED, PATIENT SUFFERED EXTREME PAIN IN HER HIP, CAUSING DIFFICULTY AMBULATING AND SLEEPING. ADDITIONALLY, PATIENT LEARNED THAT HER ASR WAS RELEASING METAL IONS INTO HER BODY. ON (B)(6) 2010, PATIENT HAD HER IMPLANT REVISED AND REPLACED WITH DIFFERENT HIP IMPLANT COMPONENTS. DOI: (B)(6) 2009 - DOR: (B)(6) 2010 (RIGHT SIDE). PATIENT RESIDES IN (B)(6). UPDATE: (B)(6) 2011 - MEDICAL RECORDS RECEIVED. PART/LOT NUMBER IDENTIFIED WITH INVOICE SEARCH. 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

    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

    LITIGATION PAPERS ALLEGE: ON (B)(6) 2009, PT HAD THE ASR XL SYSTEM IMPLANTED INTO HER RIGHT HIP. AFTER HAVING THE ASR IMPLANTED, PT SUFFERED EXTREME PAIN IN HER HIP, CAUSING DIFFICULTY AMBULATING AND SLEEPING. ADDITIONALLY, PT LEARNED THAT HER ASR WAS RELEASING METAL IONS INTO HER BODY. ON (B)(6) 2010, PT HAD HER IMPLANT REVISED AND REPLACED WITH DIFFERENT HIP IMPLANT COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR CUP TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention