BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 3895455 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21985
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 6, 2014
    Report Date
    July 9, 2014
    Manufacturer
    DEPUY INTERNATIONAL 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

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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. REF. (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, ASR XL/RESURFACING - UNKNOWN. UNKNOWN HIP SIDE, REASON(S) FOR REVISION : UNKNOWN. UPDATE - ADDED TYPE OF REPLACEMENT, SIDE OF HIP, REPLACED DUMMY PRODUCT WITH PRODUCTS X 2, ADDED SURGEON AND HOSPITAL. TAKEN FROM CLAIMSUITE DATED (B)(6) 2014. LEFT, ASR HIP RESURFACING SYSTEM.

    Description of Event or Problem · 1

    ASR REVISION. ASR XL/RESURFACING - UNKNOWN. UNKNOWN HIP SIDE REASON(S) FOR REVISION. : UNKNOWN. UPDATE - ADDED TYPE OF REPLACEMENT, SIDE OF HIP, REPLACED DUMMY PRODUCT WITH PRODUCTS X 2, ADDED SURGEON AND HOSPITAL. TAKEN FROM (B)(6) DATED 25TH JUNE 2014. LEFT ASR HIP RESURFACING SYSTEM. UPDATE - ADDED REASON FOR REVISION, ADDITIONAL SURGEON AND ATTACHED SURGEON FORM. TAKEN FROM SURGEON FORM DATED 9TH JULY 2014 AND (B)(6) DATED 10TH JULY 2014. REASON(S) FOR REVISION: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370025 TOTAL ASR ACET IMP SIZE 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 1812835

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention