BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 4607094 · Received March 17, 2015

    Report

    Report Number
    1818910-2015-16280
    Event Type
    Injury
    Date Received
    March 17, 2015
    Date of Event
    February 11, 2015
    Report Date
    March 3, 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

    ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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 TO TAKE PLACE ON (B)(6) 2015 ASR XL - RIGHT REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION ** BI-LATERAL PATIENT - FOR LEFT HIP PLEASE SEE COM 080955 ** **UPDATE** 2 FEB 2015 - REVISION SURGERY NOW SCHEDULED FOR (B)(6) 2015 UPDATE - RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM (B)(6) SPREADSHEET DATED 3RD MARCH 2015 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 TO TAKE PLACE ON (B)(6) 2015; ASR XL - RIGHT. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. BI-LATERAL PATIENT - FOR LEFT HIP PLEASE SEE (B)(4). UPDATE 2 FEB 2015 - REVISION SURGERY NOW SCHEDULED FOR (B)(6) 2015. UPDATE - RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM (B)(4) SPREADSHEET DATED (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179801 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2494814

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention