BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 1983406 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01270
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 26, 2010
    Report Date
    March 12, 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 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.

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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

    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

    PATIENT WAS REVISED TO ADDRESS ALVAL/SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT (B)(4) REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION. UPDATE FROM (B)(6)'S SPREADSHEET (B)(6) 2012: REASON FOR REVISION, PRODUCTS, HIP REVISED, DESC, HOSPITAL. ASR REVISION, LEFT ASR HIP RESURFACING SYSTEM, REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION. UPDATE - AMENDED IMPLANT DATE TAKEN FROM CLAIMSUITE DATED (B)(6) 2015. SURGERY DATE: (B)(6) 2008.

    Description of Event or Problem · 1

    ASR REVISION.

    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 2549795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention