BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 60

    MDR report key: 5416015 · Received February 8, 2016

    Report

    Report Number
    1818910-2016-12849
    Event Type
    Injury
    Date Received
    February 8, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 1, 2016
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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. WWCAPA (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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    ASR REVISION RECOMMENDEDLEFTXLREASON FOR REVISION : UNKNOWN** UPDATE - ALERT DATE (B)(6) 2017 **CLAIMSUITE & SCF RECEIVED.REASONS FOR REVISION CONFIRMED - COMPONENT LOOSENING / PAIN / NOISE / ALVAL / SOFT TISSUE REACTION / INCREASED COBALT.ADDED PATIENT HARMS, ADDITIONAL SUEGEON NAME, HOSPITAL NAME, AMENDED DATE OF IMPLANT, ADDED REVISION DATE, AMENDED PRODUCT COMPLAINT CATEGORY FOR ALL PRODUCTS AND ADDED PRODUCT AWARENESS DATE & FAILURE CODE TAKEN FROM SCF/CLAIMSUITE DATED (B)(6).EK (B)(6) 2017.**********************************UPDATE AUG 30, 2017: EMAIL NOTIFICATION FROM (B)(6) RECEIVED. THERE IS NO NEW INFORMATION. THIS COMPLAINT WAS UPDATED ON: SEP 4, 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 RECOMMENDED. LEFT - XL. REASON FOR REVISION : UNKNOWN.

    Description of Event or Problem · 1

    UPDATE - ALERT DATE 14 FEB 2017: REASONS FOR REVISION CONFIRMED - COMPONENT LOOSENING (UNKNOWN DEVICE)/ PAIN / NOISE / ALVAL / SOFT TISSUE REACTION / INCREASED COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74365 TOTAL ASR ACET IMP SIZE 60 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2740023

    Patients

    Seq Age Sex Outcome Treatment
    1 Other