BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 2943596 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-01590
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    December 4, 2012
    Report Date
    April 27, 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

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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

    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

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

    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 - RECOMMENDED, ASR XL - LEFT, REASON(S) FOR REVISION: UNKNOWN. UPDATE- ADDED SLEEVE, AMENDED ORIGINAL SURGERY DATE. TAKEN FROM CLAIMSUITE DATED (B)(6) 2012. UPDATE- ADDED REVISION DATE TAKEN FROM CLAIMSUITE DATED (B)(6) 2013. UPDATE - ADDED REASON FOR REVISION TAKEN FROM CLAIMSUITE DATED (B)(6) 2013. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE RECEIVED (B)(6) 2014. KID NUMBER ADDED, AMENDED TO LEGAL, SURGERY DATE AMENDED.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL - LEFT, REASON(S) FOR REVISION: 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 - RECOMMENDED. ASR XL - LEFT. REASON(S) FOR REVISION: UNKNOWN. UPDATE- ADDED SLEEVE, AMENDED ORIGINAL SURGERY DATE. TAKEN FROM CLAIMSUITE DATED 3RD DECEMBER 2012. UPDATE- ADDED REVISION DATE TAKEN FROM CLAIMSUITE DATED 29TH JAN 2013. UPDATE - ADDED REASON FOR REVISION TAKEN FROM CLAIMSUITE DATED 23RD APRIL 2013. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. ***UPDATE RECEIVED 5TH SEPTEMBER 2014. KID NUMBER ADDED, AMENDED TO LEGAL, SURGERY DATE AMENDED.*** UPDATE - AMENDED IMPLANT DATE, ADDED STEM AND STEM SLEEVE, ADDED ALL EXPIRY DATES. TAKEN FROM CLAIMSUITE DATED 27TH APRIL 2015. SURGERY DATE: (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47657 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2494015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention