BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 50

    MDR report key: 2071438 · Received April 13, 2011

    Report

    Report Number
    1818910-2011-05906
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    June 22, 2015
    Report Date
    June 22, 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
    AS
    Reporter Occupation
    OTHER

    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

    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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: THE PATIENT, (B)(4), HAD ORIGINAL HIP SURGERY ON (B)(6) 2007 AND BOOKED FOR REVISION ON (B)(6) 2011. UPDATE FROM REP: (B)(6) 2011: ASR RECALL PATIENT. BLOOD LEVEL 16.12.10, CHROMIUM 214, COBALT 491. OSTEOLYSIS IN PUBIS EVIDENT AT TIME OF REVISION. "DEAD SPACE" IN HEAD FULL OF MATTER. CLAIMSUITE REFERENCE: (B)(4). UPDATE: 22 JUNE 2015: UPDATED HIP SIDE AS LEFT HIP, UPDATED ORIGINAL IMPLANT DATE AS (B)(6) 2007. UPDATED FILE HANDLER DETAILS, ADDED MANUFACTURE AND EXPIRY DATES FOR ALL PRODUCTS. TAKEN FROM CLAIMSUITE UPDATE 22 JUNE 2015. ((B)(4)).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS ELEVATED COBALT CHROMIUM LEVELS, OSTEOLYSIS, AND DEBRIS IN THE FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 1852340

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention