BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 52

    MDR report key: 2834325 · Received November 15, 2012

    Report

    Report Number
    1818910-2012-25183
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    July 16, 2012
    Report Date
    January 28, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE ASR XL HIP IMPLANT. THE REASON FOR THE REVISION IS UNEXPLAINED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED FUNCTIONAL IMPAIRMENT, NIGHT PAIN, AND RESTRICTED RANGE OF MOTION. IT WAS FURTHER REPORTED THAT BOTH CHROMIUM AND COBALT WERE FOUND IN THE BLOOD OF THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL REASONS FOR REVISION: PAIN, INCREASED COBALT AND CHROMIUM LEVELS, TUMOUR AND FLUID AROUND IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 52 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2334132

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention