BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 43

    MDR report key: 2150841 · Received June 29, 2011

    Report

    Report Number
    1818910-2011-11345
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    April 24, 2012
    Report Date
    April 17, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    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

    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    THE PT HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNK.

    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: ASR REVISION BI-LATERAL. ASR HIP RESURFACING SYSTEM (LEFT); ASR HIP RESURFACING SYSTEM (RIGHT); UPDATE RECEIVED: 25TH OCTOBER 2013 - AMENDED PRODUCT: FROM SPACER TO CUP. UPDATE RECEIVED: 5TH NOVEMBER 2013 - AMENDED IMPLANT DATE: 15TH NOVEMBER 2007, CLARIFIED REVISION DATES, ADDED REVISION DATE FOR RIGHT SIDE AND CLARIFIED WHICH PRODUCT BELONGS TO WHICH SIDE (SEE DROP DOWN ON PRODUCT PAGES). LEFT SIDE REVISION DATE: (B)(6) 2013. RIGHT SIDE REVISION DATE: (B)(6) 2012. UPDATE - QUERYING MISSING HOSPITAL, SURGEON AND REASONS FOR REVISION FOR BOTH HIP SIDES. ADDED LOT NUMBER TO CUP FOR LEFT SIDE. ADDED ALL PRODUCT EXPIRY AND MANUFACTURING DATES FOR BOTH SIDE HIPS, FILLED OUT ALL MISSING MW FIELDS. FILLED IN "DATE OF REVISION" CATEGORY WITH THE LEFT SIDE REVISION DATE. RIGHT SIDE REVISION DATE DESCRIBED BELOW. TAKEN FROM CLAIMSUITE DATED 17TH APRIL 2015. LOT NUMBER FOR LEFT CUP - 2386871. RIGHT SIDE REVISION DATE - (B)(6) 2012. UPDATE - RIGHT SIDE IMPLANT DATE HAS BEEN PROVIDED , THIS IS THE ONLY INFO AVAILABLE FOR THE RIGHT SIDE "NO FURTHER INFO AVAILABLE: ADVISED OF REVISION BY SOLICITOR.", AMENDED REVISION DATE FOR LEFT SIDE AND ADDED THE SURGEON, HOSPITAL AND REASON FOR REVISION FOR LEFT SIDE. ALSO ATTACHED THE SCF FOR THE LEFT SIDE. TAKEN FROM EMAIL DATED 21ST APRIL 2015 . RIGHT SIDE IMPLANT DATE - (B)(6) 2006. RIGHT SIDE REVISION DATE - (B)(6) 2012. LEFT SIDE IMPLANT DATE - (B)(6) 2007. LEFT SIDE REVISION DATE - (B)(6) 2010. (B)(6). LEFT SIDE HOSPITAL - (B)(6) HOSPITAL. LEFT SIDE REASONS FOR REVISION - PAIN, NOISE, ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 43 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2097324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention