BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 51

    MDR report key: 2901990 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-00135
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 8, 2011
    Report Date
    August 11, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    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

    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 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

    ASR REVISION; ASR XL ACETABULAR SYSTEM - RIGHT HIP; REASON FOR REVISION: COMPONENT LOOSENING.

    Description of Event or Problem · 1

    REVISION WAS DUE TO THE ACETABULAR CUP BEING LOOSE, NOT THE FEMORAL IMPLANT.

    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. ASR XL ACETABULAR SYSTEM - RIGHT. REASON(S) FOR REVISION: COMPONENT LOOSENING - CUP. UPDATE: EMAIL RECEIVED 09 JAN 2013 CONFIRMING CUP AS COMPONENT LOOSE. ***UPDATE RECEIVED 18TH JUNE 2014. HOSPITAL NAME AMENDED. CONFIRMATION THAT STEM WAS NON-DEPUY PRODUCT.***

    Description of Event or Problem · 1

    NEW (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR XL ACETABULAR SYSTEM - RIGHT. REASON(S) FOR REVISION: COMPONENT LOOSENING - CUP. UPDATE: EMAIL RECEIVED 09 JAN 2013 CONFIRMING CUP AS COMPONENT LOOSE. UPDATE RECEIVED 18TH JUNE 2014. HOSPITAL NAME AMENDED. CONFIRMATION THAT STEM WAS NON-DEPUY PRODUCT. THIS COM IS TO BE CLOSED TO CAPA DUE TO THE REASONS FOR REVISION FALLING WITHIN THE CAPA REMIT AND OFF LABEL USE OF A COMPETITOR STEM UPDATE CONFIRMATION OF IMPLANT DATES RECEIVED FROM CRAWFORDS 11 AUG 2014. DOI (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9017 DEPUY ASR XL FEM IMP SIZE 51 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2667820

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention