BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ACETABULAR CUP

    MDR report key: 3121665 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-06807
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 6, 2013
    Report Date
    August 13, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: SEVERE PAIN; PSEUDOTUMOR; ELEVATED ION LEVELS; MINIMAL METALLOSIS. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223722 UNKNOWN DEPUY ACETABULAR CUP ACETABULAR CUP KWA DEPUY INTERNATIONAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention