BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 3160742 · Received June 10, 2013

    Report

    Report Number
    1818910-2013-18547
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 21, 2013
    Report Date
    August 16, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. 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

    PATIENT WAS REVISED DUE TO PAIN. IT WAS ALSO REPORTED BY SALES REP THAT THE SURGEON STATED MECHANICAL FAILURE.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: METALLOSIS; SLIGHT PAIN; ELEVATED METAL IONS; LARGE AMOUNT OF SCAR TISSUE; LARGE AMOUNT OF FLUID; SPREADING CORROSION ON MODULAR LINER; SLIGHT AMOUNT OF WEAR ON HEAD. ADAPTER SLEEVE AND FEMORAL STEM HAVE BEEN ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261184 ASR ACETABULAR CUPS 60 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2322926

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention