BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HEAD

    MDR report key: 2232251 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-16036
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 20, 2026
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1748/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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 (B)(4) WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 2010, AND THE (B)(4) 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.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION: LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED SEVERE PAIN AND POSSIBLY PERMANENTLY DISABLING INJURIES AND HAD TO BE REVISED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention