BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 48

    MDR report key: 1989529 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-00801
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 3, 2015
    Manufacturer
    DEPUY INTL LTD
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA. (B)(4).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: RECOMMENDED ASR REVISION. BI-LATERAL, ASR XL ACETABULAR SYSTEM (RIGHT), REASON(S) FOR REVISION: PAIN. UPDATE: LOT NUMBERS, DATE OF REVISION, REASON FOR REVISION, HOSPITAL, SYSTEM AND REVISED HIP FROM CRAWFORDS SPREADSHEET DATED 17 JAN 2012. LOT NOS. 2903713, 2876219 AND 2924849 FOR LEFT HIP NOT REVISED. UPDATE- RIGHT- ADDED A STEM, TAKEN FROM CLAIMSUITE DATED 21ST NOVEMBER 2012. UPDATE: 9 JULY 2015. UPDATED TO LEGAL WITH (B)(6). PRODUCTS FOR LEFT AND RIGHT HIPS WERE RECORDED ON THE SAME DINT. TWO COMS NOW CREATED, ONE FOR EACH HIP. FOR DETAILS OF LEFT HIP (B)(4). ADDED MANUFACTURE AND EXPIRY DATES FOR PRODUCTS. TAKEN FROM (B)(6) ALERT 3 JULY 2015. (PD 9 JULY 2015)

    Description of Event or Problem · 1

    ON (B)(6) 2012 INFORMATION WAS RECEIVED THAT THE PATIENT WAS REVISED BECAUSE OF PAIN.

    Description of Event or Problem · 1

    RECOMMENDED ASR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 48 HIP ACETABULAR CUP KWA DEPUY INTL LTD NA 2746272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention CORAIL2 NON COL HO SIZE 12| DEPUY ASR XL FEM IMP SIZE 43| TAPER SLEEVE ADAPTER 12/14 +8