BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 58

    MDR report key: 2868272 · Received December 11, 2012

    Report

    Report Number
    1818910-2012-25796
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 6, 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

    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. THIS IS A DUPLICATE REPORT OF 1818910-2014-241442. THIS REPORT, 1818910-2012-25796, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2014-241442.

    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

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPL FOR ORIGINAL COMPLAINT: ASR REVISION LEFT ASR HIP RESURFACING SYSTEM REASON(S) FOR REVISION: PAIN UPDATE- UPDATED ORIGINAL SURGERY DATE, ADDED HOSPITALS, SURGEON, UPDA FROM FORM 73 DATED 17TH JAN 2013 REASON FOR REVISION: PAIN, ALVAL UPDATE REC'D 19 SEP 2013 - ADDED FORM 73 UPDATE 6 OCT 2015: COM WAS DUPLICATED IN COM (B)(4) WHICH WILL NO THAT COM TO THIS COMPLAINT - MARKED AS LEGAL, ADDED KID, SURGEON FIRST FILLED IN MISSING INFO INC PRODUCT DETAILS AND MW FIELDS. SM 6 OCT 2015 THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY C 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

    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;LEFT ASR HIP RESURFACING SYSTEM;REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    UPDATE 6 OCT 2015: COM WAS DUPLICATED IN (B)(4) WHICH WILL NOW BE VOIDED. ADDED INFO FROM THAT COM TO THIS COMPLAINT - MARKED AS LEGAL, ADDED KID, SURGEON FIRST NAME, ADDITIONAL HOSPITAL. ALSO FILLED IN MISSING INFO INC PRODUCT DETAILS AND MW FIELDS.

    Description of Event or Problem · 1

    ADDITIONAL REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 58 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2813574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention