BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 60

    MDR report key: 4858281 · Received June 21, 2015

    Report

    Report Number
    1818910-2015-24022
    Event Type
    Injury
    Date Received
    June 21, 2015
    Date of Event
    May 4, 2015
    Report Date
    June 10, 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
    ATTORNEY

    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. 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. (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. (B)(4).

    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

    ASR REVISION DUE TO TAKE PLACE ON (B)(6) 2015 LEFT RESURFACING REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION / PAIN THIS IS A BILATERAL PATIENT. FOR RIGHT SIDE SEE COM 072432 UPDATE - RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM CRAWFORDS SPREADSHEET DATED (B)(6) 2015 UPDATE NOV 17, 2017: EMAIL NOTIFICATION RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: NOV 21, 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 DUE TO TAKE PLACE ON (B)(6) 2015. LEFT. RESURFACING. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION / PAIN. THIS IS A BILATERAL PATIENT. FOR RIGHT SIDE SEE COM (B)(4). UPDATE - RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM (B)(6) SPREADSHEET DATED (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402235 TOTAL ASR ACET IMP SIZE 60 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD.8010379 2569124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention