BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPER SLEEVE ADAPTER 12/14 +2

    MDR report key: 4960541 · Received August 3, 2015

    Report

    Report Number
    1818910-2015-27199
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 23, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    JDG
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. 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. (B)(4).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT 22325. REASON FOR ORIGINAL COMPLAINT: ASR REVISION RIGHT ASR XL ACETABULAR SYSTEM REASON FOR REVISION: PAIN DATE OF REVISION: (B)(6) 2012 - THE PATIENT HAS CANCELLED THE REVISION SURGERY UPDATE 24 JULY 2015: UPDATED REVISION DATE AS (B)(6) 2015, ADDED STEM AND SLEEVE DETAILS, QUERYING LOT NUMBERS AS THEY ARE INCORRECT ON THE SCF. ADDED ALVAL / SOFT TISSUE REACTION AS REASON FOR REVISION. TAKEN FROM CLAIMSUITE UPDATE 23 JULY 2015 AND SCF 22 JULY 2015. (PD 24 JULY 2015 UPDATE 27 JULY 2015: ADDED LOT NUMBERS, MANUFACTURE AND EXPIRY DATES FOR CUP, HEAD AND SLEEVE, LOT NUMBER FOR STEM NOT AVAILABLE. TAKEN FROM QUERY 2 REPLY 27 JULY 2015 (PD 27 JULY 2015).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504904 TAPER SLEEVE ADAPTER 12/14 +2 HIP FEMORAL STEM/SLEEVE JDG DEPUY INTL., LTD. - 8010379 2237663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention