BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 7408271 · Received April 9, 2018

    Report

    Report Number
    1818910-2018-56939
    Event Type
    Injury
    Date Received
    April 9, 2018
    Report Date
    March 12, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:  (B)(4). INVESTIGATION SUMMARY 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER (B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. 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. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT PRODUCT CODE WAS SOLD INTERNATIONALLY. IT WAS SOLD IN THE US UNDER A DIFFERENT PRODUCT CODE.  THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Description of Event or Problem · 1

    ITALIAN ASR DOCUMENT RECEIVED. INITIATED TRANSLATION PROCESS. ON (B)(6) 2018: ASR ENGLISH TRANSLATED LITIGATION RECORD RECEIVED. LITIGATION ALLEGES DEFECTIVE IMPLANTS, WORSENING PAIN, DIFFICULTY WALKING, GETTING TIRED EASILY, PAIN ON WEIGHT BEARING ON AFFECTED LIMB, DEVELOPMENT OF LEFT COXALGIA, PARESTHESIA AND PSYCHOLOGICAL EFFECTS. DOI: (B)96) 2007 ; DOR: NOT REPORTED (RIGHT HIP) ASR. THIS COMPLAINT WAS UPDATED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252629 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention