BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 2112602 · Received May 19, 2011

    Report

    Report Number
    1818910-2011-08575
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    May 2, 2008
    Report Date
    April 19, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE SINCE THE SURGICAL IMPLANTATION OF THE ASR XL ACETABULAR SYSTEM IN HIS LEFT HIP, PATIENT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO SWELLING, INFLAMMATION, HIP PAIN, LOOSENING OF THE DEVICE, INFECTION AND PROBLEMS SITTING, STANDING AND MOVING UP AND DOWN STAIRS. AS A RESULT, ON OR ABOUT (B)(6), 2008, PATIENT REQUIRED SURGERY TO REMOVE THE ASR XL ACETABULAR SYSTEM FROM HIS LEFT HIP AND REPLACE IT WITH AN ANTIBIOTIC SPACER. DOI: (B)(6) 2006 - DOR: (B)(6) 2008 (LEFT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE (B)(4) 2011 - PART/LOT NUMBERS IDENTIFIED FROM MEDICAL RECORDS. ADDITIONAL PRODUCTS ADDED TO THE COMPLAINT. 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 SINCE THE SURGICAL IMPLANTATION OF THE ASR XL ACETABULAR SYSTEM IN HIS LEFT HIP, PT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO SWELLING, INFLAMMATION, HIP PAIN, LOOSENING OF THE DEVICE, INFECTION AND PROBLEMS SITTING, STANDING AND MOVING UP AND DOWN STAIRS. AS A RESULT, ON OR ABOUT (B)(6), 2008, PT REQUIRED SURGERY TO REMOVE THE ASR XL ACETABULAR SYSTEM FROM HIS LEFT HIP AND REPLACE IT WITH AN ANTIBIOTIC SPACER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention