BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 60

    MDR report key: 2339067 · Received November 16, 2011

    Report

    Report Number
    1818910-2011-23323
    Event Type
    Injury
    Date Received
    November 16, 2011
    Report Date
    April 4, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. 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 STILL CONSIDERS THE INVESTIGATION CLOSED. 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 REVISIONREASON FOR REVISION: COMPONENT LOOSENING. ALVAL / PAIN.

    Description of Event or Problem · 1

    NEW (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. LEFT ASR XL. REASON FOR REVISION: COMPONENT LOOSENING. ALVAL / PAIN. SUPPLIED LOT NO 1945385 DOES NOT MATCH PRODUCT NO. LOT NO 1954385 USED INSTEAD. UPDATE: EXTRA PRODUCT INFORMATION (CANNOT IDENTIFY LOT NUMBERS FOR 2 PRODUCTS) AND ADDITIONAL REASONS FOR REVISION FROM FORM 57 VERIFIED FROM (B)(6) UPDATE SPREADSHEET 28 OCT 2011. UPDATE RECEIVED: 4TH APRIL 2014 - ATTACHED LEGAL DOCUMENT, MARKED AS LEGAL, ADDED (B)(6) REFERENCE NUMBER, ADDED HOSPITAL: (B)(6) HOSPITAL, ADDED SURGEON: MR (B)(6), ADDED PATIENT NAME, ADDED PATIENT DATE OF BIRTH, ADDED PATIENT GENDER, ADDED PATIENT ID (INITIALS) AND ADDED TAPER SLEEVE AND CUP LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 60 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL 2210748

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention