BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 53

    MDR report key: 2225174 · Received August 29, 2011

    Report

    Report Number
    1818910-2011-16742
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    January 28, 2011
    Report Date
    April 4, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    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

    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.

    Additional Manufacturer Narrative · 1

    CORRECTED: DESCRIBE EVENT OR PROBLEM, PATIENT CODE. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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.

    Description of Event or Problem · 1

    UPDATE: THE PATIENT WAS REVISED BECAUSE OF LOOSENING, ALVAL/SOFT TISSUE REACTION, AND 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.

    Description of Event or Problem · 1

    ASR REVISION: LEFT ASR XL. REASON FOR REVISION: COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 53 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 1954385

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention