BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 49

    MDR report key: 2333582 · Received November 11, 2011

    Report

    Report Number
    1818910-2011-23477
    Event Type
    Injury
    Date Received
    November 11, 2011
    Date of Event
    September 8, 2011
    Report Date
    March 24, 2015
    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

    DEPUY STILL 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

    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.

    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

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION, ASR HIP RESURFACING SYSTEM (RIGHT); ASR XL ACETABULAR SYSTEM (LEFT), REASON(S) FOR REVISION: UNKNOWN. UPDATE - IDENTIFIED PRODUCTS FOR RIGHT HIP AND ADDED REVISION DATE, AND ADDED HOSPITAL FROM CLAIMSUITE EMAIL DATED (B)(6) 2012. HIP(S) TO BE REVISED: RIGHT. 999804956 / 2233154; 999890149 / 2377895 DATE OF REVISION: (B)(6) 2011. UPDATE: HAVE RECEIVED CONFIRMATION OF DETAILS REGARDING THE LEFT HIP REVISION, (B)(6) 2012. HIP(S) TO BE REVISED: LEFT. 999804956 / 2171125; 999890149 / 2194761 DATE OF REVISION: (B)(6) 2011. UPDATE- UPDATED REASON FOR REVISION TAKEN FROM CLAIMSUITE DATED (B)(6) 2013. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. LEFT. UPDATE 24 MAR 2015 - (BILATERAL RIGHT (B)(4)) ADDED SLEEVE AND CONFIRMED THAT NO STEM DETAILS ARE AVAILABLE. ((B)(6) 2015) IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    CORRECTED/UPDATED DATA: (DATE OF EVENT); (DATE OF REPORT); (EVENT DESCRIPTION); (EXPLANT DATE); (DEVICE AVAILABILITY); (DATE RECEIVED BY MANUFACTURER). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED. (B)(4).

    Description of Event or Problem · 1

    ASR REVISION - ASR HIP RESURFACING SYSTEM (RIGHT); ASR XL ACETABULAR SYSTEM (LEFT). REASON(S) FOR REVISION : UNKNOWN.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE ASR LEFT HIP IMPLANT. THE REASON FOR THE REVISION IS UNKNOWN.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR HIP RESURFACING SYSTEM (RIGHT); ASR XL ACETABULAR SYSTEM (LEFT). REASON(S) FOR REVISION : UNKNOWN. UPDATE - IDENTIFIED PRODUCTS FOR RIGHT HIP AND ADDED REVISION DATE, AND ADDED HOSPITAL FROM CLAIMSUITE EMAIL DATED 11TH OCTOBER 2012 HIP(S) TO BE REVISED: RIGHT. 999804956 / 2233154 ; 999890149 / 2377895. DATE OF REVISION: (B)(6) 2011. UPDATE: HAVE RECEIVED CONFIRMATION OF DETAILS REGARDING THE LEFT HIP REVISION, (B)(6) 2012. HIP(S) TO BE REVISED: LEFT. 999804956 / 2171125; 999890149 / 2194761. DATE OF REVISION: (B)(6) 2011. UPDATE- UPDATED REASON FOR REVISION TAKEN FROM CLAIMSUITE DATED 30TH JAN 2013 REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. LEFT. UPDATE 24 MAR 2015 - (BILATERAL RIGHT (B)(4)) ADDED SLEEVE AND CONFIRMED THAT NO STEM DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 49 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD.8010379 2194761

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention