BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 2163267 · Received July 8, 2011

    Report

    Report Number
    1818910-2011-12686
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    April 26, 2011
    Report Date
    July 5, 2014
    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 Occupation
    UNKNOWN

    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. REF. (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

    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 PATIENT WAS REVISED TO ADDRESS PAIN.

    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. LEFT ASR XL ACETABULAR SYSTEM - DATE OF REVISION (B)(6) 2011. PRODUCT LOT NOS FOR LEFT HIP: 2283206, 2319272. RIGHT XL ACETABULAR SYSTEM - DATE OF REVISION (B)(6) 2011. PRODUCT LOT NOS FOR RIGHT HIP: 2816980, 2877583. REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION. UPDATE FROM (B)(6) SPREADSHEET 28 OCT 2011: DATE OF REVISION, PRODUCTS, REASON FOR REVISION, SURGEON, BI-LATERAL DESCRIPTION ADDED. UPDATE RECEIVED: 5TH JULY 2014 - ADDED IMPLANT DATES: LEFT IMPLANT DATE: (B)(6) 2007. RIGHT IMPLANT DATE: (B)(6) 2009. UPDATE RECEIVED: 10TH JULY 2014 - ADDED PRODUCTS: LEFT TAPER SLEEVE AND RIGHT TAPER SLEEVE, ADDED SURGEON TITLE: MR AND ADDED FURTHER REASON FOR REVISION FOR RIGHT SIDE: PAIN AND ADDED CENTRE ON THE END OF HOSPITAL. LEFT REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION. RIGHT REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2283206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention