BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 1983483 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01542
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 1, 2010
    Report Date
    August 7, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA AND THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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).

    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 CASE CLOSED TO CAPA. (B)(4).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: THE PATIENT HAD PAIN ON THE RIGHT SIDE AND IS THEREBY HANDICAPPED. THERE IS A UNUSUAL AMOUNT OF COBALT IN THE BLOOD, SO THE DOCTOR IS SUSPICIOUS OF METALLOSIS. FIRST OPERATION WAS ON (B)(6) 2009. RE-OPERATION WAS ON (B)(6) 2010. (B)(6) HAVE THE PRODUCTS AND WILL HOLD TO SEND TO THIRD PARTY WHEN ADVISED TO DO SO. UPDATE - ADDED STEM AND SLEEVE, AMENDED IMPLANT DATE, ADDED KID NUMBER AND MARKED AS LEGAL. TAKEN FROM KENNEDYS EMAIL DATED 7TH AUGUST 2015

    Description of Event or Problem · 1

    THE PT HAD PAIN ON THE RIGHT SIDE AND IS THEREBY HANDICAPPED. THERE IS AN UNUSUAL AMOUNT OF COBALT IN THE BLOOD, SO THE DOCTOR IN SUSPICIOUS OF METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 NA 2872788

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention