BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 2210377 · Received August 8, 2011

    Report

    Report Number
    1818910-2011-15105
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    November 17, 2009
    Report Date
    October 14, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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.

    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).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS LOOSENING.

    Description of Event or Problem · 1

    (B)(4). ASR REVISION.ASR HIP RESURFACING SYSTEM (LEFT).REASON FOR REVISION: COMPONENT LOOSENING.UPDATE - QUERYING REASON FOR REVISON COMP LOOSENING, ADDED ADDITIONAL HOSPITAL. TAKEN FROM CLAIMSUITE DATED (B)(4) 2014 -BOTH CUP AND HEAD WERE LOOSE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 1195502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention