BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ASR ACET IMP SIZE 50

    MDR report key: 3001331 · Received March 13, 2013

    Report

    Report Number
    1818910-2013-03059
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 6, 2013
    Report Date
    September 11, 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
    SF
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    1818910-2013-03064 IS A DUPLICATE REPORT OF THIS REPORT, 1818910-2013-03059. 1818910-2013-03064 WILL BE REJECTED. 1818910-2013-03059 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    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

    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, ASR HIP RESURFACING SYSTEM - RIGHT. REASON(S) FOR REVISION: PAIN; COMPONENT LOOSENING (CUP); ALVAL SOFT TISSUE DAMAGE.

    Description of Event or Problem · 1

    11 SEPT 2015 - UPDATE - LEGAL - ADDED KID NUMBER , PRODUCT NAMES AND MANU PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105730 TOTAL ASR ACET IMP SIZE 50 TOTAL ASR ACET IMP SIZE 50 KWA DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention