BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL TAP SLV ADAP 12/14+8

    MDR report key: 3051203 · Received April 10, 2013

    Report

    Report Number
    1818910-2013-04571
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 15, 2012
    Report Date
    January 12, 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. (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

    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

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

    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 RECOMMENDED. ASR XL ACETABULAR SYSTEM - RIGHT HIP. REASON(S) FOR REVISION: UNKNOWN. UPDATE: ADDED PRODUCT AND REVISION DATE. RECEIVED: APRIL 3RD 2013. UPDATE - ADDED LOT NUMBER TO HEAD TAKEN FROM CLAIMSUITE DATED 10TH APRIL 2014. UPDATE - ADDED REASON FOR REVISION AND EXPIRY DATES. (QUERYING MISSING STEM AND HOSPITAL) TAKEN FROM CLAIMSUITE DATED 12TH JAN 2015. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION, UPDATE - HOSPITAL AND STEM DETAILS ADDED. TAKEN FROM EMAIL DATED 14TH JAN 2015, (B)(6) HOSPITAL.

    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 RECOMMENDED. ASR XL ACETABULAR SYSTEM - RIGHT HIP. REASON(S) FOR REVISION: UNKNOWN. UPDATE: ADDED PRODUCT AND REVISION DATE. RECEIVED: APRIL 3RD 2013. UPDATE - ADDED LOT NUMBER TO HEAD TAKEN FROM (B)(6) DATED 10TH APRIL 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151874 ASR XL TAP SLV ADAP 12/14+8 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD. 8010379 1175664

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention