BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR TAP SLV ADAP 12/14 -1

    MDR report key: 5507056 · Received March 17, 2016

    Report

    Report Number
    1818910-2016-15447
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    March 11, 2016
    Report Date
    January 26, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK070359
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    PMA/510(K): K070359. 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. WWCAPA (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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS HIGH METAL ION LEVELS, METALLOSIS, AND ALVAL.

    Description of Event or Problem · 1

    UPDATE 01/26/2017 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED WITHIN THE REVISION OPERATIVE NOTE THAT TISSUE SENT FOR PATHOLOGY "CAME BACK CONSISTENT WITH ALVAL TYPE REACTION". ALSO, "BEHIND THE ACETABULUM...HAD LARGE CAVITATION WITH NECROTIC TISSUE WITHIN IT AGAIN CONSISTENT WITH METALLIC REACTION". THERE ARE NO METAL ION LAB VALUES AVAILABLE TO SUPPORT THE ALLEGED HIGH METAL IONS. NECROSIS HARM SUBMITTED TO FDA. IT WAS DISCOVERED THAT THE PREVIOUSLY REPORTED UNKNOWN STEM IS IN FACT A COMPETITOR PRODUCT AND WILL BE REMOVED FROM COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164681 ASR TAP SLV ADAP 12/14 -1 HIP OTHER IMPLANT KWA DEPUY INTERNATIONAL LTD. 2470584

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention