BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2213235 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-14939
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    February 12, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    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

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS LEFT SIDE ON OR ABOUT (B)(6) 2007. PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE ON OR ABOUT (B)(6) 2008. SINCE HIS SURGERIES, PATIENT HAS EXPERIENCED PAIN. HE HAS NOT YET SCHEDULED AN EXPLANTATION OF EITHER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE: 2/12/2014 - MEDICAL RECORDS RECEIVED FOR RIGHT HIP REVISION SURGERY. PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS A CYST, FIBRINOUS DEBRIS, BONE EROSION, GRANULAR TYPE MATERIAL AND METALLOSIS. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 02/25/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2557520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention