BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 45

    MDR report key: 3022899 · Received March 27, 2013

    Report

    Report Number
    1818910-2013-04496
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 19, 2013
    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 (B)(4) 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.

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT 26722. REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION TO TAKE PLACE ON (B)(6) 2013 ASR XL ACETABULAR SYSTEM - LEFT REASON(S) FOR REVISION: PAIN ***UPDATE RECEIVED 22ND JULY, 2013. LOT NUMBER ADDED TO STEM.*** UPDATE NOV 17, 2017: EMAIL NOTIFICATION FROM (B)(6) RECEIVED. UPDATED PRODUCT INFORMATION. THIS COMPLAINT WAS UPDATED ON NOV 17, 2017. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD 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 NUMBER DINT 26722. REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION TO TAKE PLACE ON (B)(6) 2013 ASR XL ACETABULAR SYSTEM - LEFT REASON(S) FOR REVISION: PAIN ***UPDATE RECEIVED 22ND JULY, 2013. LOT NUMBER ADDED TO STEM.*** UPDATE NOV 17, 2017: EMAIL NOTIFICATION FROM (B)(6) RECEIVED. UPDATED PRODUCT INFORMATION. THIS COMPLAINT WAS UPDATED ON NOV 17, 2017. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD 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.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL ACETABULAR SYSTEM - LEFT; REASON(S) FOR REVISION: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126382 DEPUY ASR XL FEM IMP SIZE 45 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD.8010379 2482524

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention