BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 3191490 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19937
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    April 15, 2013
    Report Date
    December 10, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Additional Manufacturer Narrative · 1

    PATIENT HAS NOT YET BEEN REVISED.

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. 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. (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

    ASR REVISION - REVISION RECOMMENDED. ASR XL - RIGHT. REASON(S) FOR REVISION: UNKNOWN. UPDATE RECEIVED: (B)(6) 2013 - ADDED PATIENT DETAILS: DATE OF BIRTH, FORENAME AND SURNAME AND AMENDED REVISION DATE: YET TO TAKE PLACE, PLEASE SEE ATTACHED DOCUMENT. UPDATE REC'D (B)(6) 2013 - DATE OF IMPLANT/REVISION, SURGEON AND REASON FOR REVISION (ALVAL / SOFT TISSUE REACTION, PAIN AND METALLOSIS).

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - RIGHT; REASON(S) FOR REVISION: UNKNOWN; (B)(4). BILATERAL: SEE COM (B)(4) FOR LEFT HIP REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291473 TOTAL ASR ACET IMP SIZE 54 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2471280

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention