BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE MOD HEAD ADAPT 12/14 +5

    MDR report key: 4721567 · Received April 22, 2015

    Report

    Report Number
    1818910-2015-19294
    Event Type
    Injury
    Date Received
    April 22, 2015
    Date of Event
    January 1, 2013
    Report Date
    April 18, 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. REF. (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

    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 ASR XL ACETABULAR SYSTEM - RIGHT HIP REASON(S) FOR REVISION: UNKNOWN UPDATE - ADDED (B)(6) REFERENCE NUMBER, REASON FOR REVISION,SURGEON, HOSPITAL, AMENDED REVISION DATE, ADDED FILE HANDLER DETAILS, ADDED ALL EXPIRY AND MANUFACTURING DATES, FILLED OUT ALL MW FIELDS, QUERYING MISSING TAPER SLEEVE DETAILS. TAKEN FROM CLAIMSUITE DATED 18TH APRIL 2015 - AB ON (B)(6) 2015 REF NUMBER - 4790149 REASON(S) FOR REVISION: PAIN SURGEON'S NAME: (B)(6) HOSPITAL: (B)(6) DATE OF REVISION: (B)(6) 2013 UPDATE - TAPER SLEEVE DETAILS RECEIVED ON 22ND APRIL 2015. SEE EMAIL DATED 22ND APRIL 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, ASR XL ACETABULAR SYSTEM - RIGHT HIP, REASON(S) FOR REVISION: UNKNOWN. UPDATE - ADDED (B)(6) REFERENCE NUMBER, REASON FOR REVISION, SURGEON, HOSPITAL, AMENDED REVISION DATE, ADDED FILE HANDLER DETAILS, ADDED ALL EXPIRY AND MANUFACTURING DATES, FILLED OUT ALL MW FIELDS, QUERYING MISSING TAPER SLEEVE DETAILS. TAKEN FROM CLAIMSUITE DATED (B)(6) 2015. REF NUMBER - (B)(4). REASON(S) FOR REVISION: PAIN, SURGEON'S NAME: (B)(6). HOSPITAL: (B)(6). DATE OF REVISION: (B)(6) 2013. UPDATE - TAPER SLEEVE DETAILS RECEIVED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266967 LARGE MOD HEAD ADAPT 12/14 +5 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTERNATIONAL LTD. 8010379 2129466

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention