BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 4260456 · Received November 18, 2014

    Report

    Report Number
    1818910-2014-31908
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    October 27, 2010
    Report Date
    October 20, 2014
    Manufacturer
    DEPUY INTL., LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. 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 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. RECEIVED. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT - MEDWATCH REPORT STATES: THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR REMOVAL AND REPLACEMENT OF RECALLED DEPUY LEFT ACETABULAR COMPONENT LINER AND FEMORAL HEAD. THIS HIP PROSTHESIS WAS PLACED (B)(6) 2006. THE PATIENT DID WELL FOR TWO YEARS BEFORE HE STARTED HAVING A CLUNKING SENSATION AND PAIN IN HIS OPERATIVE HIP. HE MOST RECENTLY DEVELOPED SCIATIC NERVE TYPE SYMPTOMS WITH RADIATING PAIN ALL THE WAY DOWN HIS LEG. WHEN THE RECALL CAME OUT THE PATIENT WAS SENT FOR SERUM ION STUDIES WHICH WERE MARKEDLY ELEVATED ALTHOUGH X-RAYS DID NOT SHOW EVIDENCE OF SIGNIFICANT BONE LOSS. HE DID HAVE SIGNIFICANT SYMPTOMS AND COUPLED WITH THE IONS WARRANTED THE HIP REVISION. EXEMPLA CORPORATE RISK MANAGEMENT HAS POSSESSION OF THE EXPLANTED DEVICE PER REQUEST OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744153 ADAPTER SLEEVES 12/14 +2 HIP OTHER IMPLANT KWA DEPUY INTL., LTD - 8010379 2092452

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention