BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 48

    MDR report key: 2162221 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12134
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    March 11, 2015
    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 Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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.

    Description of Event or Problem · 1

    (B)(4). ASR REVISION.ASR XL ACETABULAR SYSTEM (RIGHT).REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.UPDATE- ADDED STEM AND SLEEVE TAKEN FROM CLAIMSUITE DATED NOVEMBER 3RD 2012.UPDATE - AMENDED IMPLANT DATE TAKEN FROM CLAIMSUITE DATED 11TH MARCH 2015.SURGERY DATE: (B)(6) 2006.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 48 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 1814529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention