BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 3030329 · Received April 2, 2013

    Report

    Report Number
    1818910-2013-04135
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 16, 2011
    Report Date
    March 5, 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

    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. REF. (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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE BILATERAL PATIENT SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SORENESS AND DIFFICULTY WALKING. DOI: 2010 - NO REPORTED REVISION. PATIENT IS RESIDENT OF (B)(6). UPDATE: MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS INDICATE LEFT SIDE WAS REVISED (B)(6 )2012 AND HETEROTOPIC OSSIFICATION WAS NOTED IN RECORDS. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOR: (B)(6) 2012 (LEFT HIP). UPDATE PLAINTIFFS FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. THERE IS NO NEW INFORMATION THAT CHANGES THE OUTCOME OF THIS INVESTIGATION. UPDATE: - PATIENTS OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS A FAILED TOTAL HIP REPLACEMENT. THE FEMORAL HEAD THE ACETABULAR CUP WERE REVISED. (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135235 ASR ACETABULAR CUPS 58 CUP KWA DEPUY INTERNATIONAL 2658312

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention