BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 52

    MDR report key: 2760140 · Received September 26, 2012

    Report

    Report Number
    1818910-2012-75572
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 5, 2017
    Report Date
    September 28, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    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).DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA (B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED PAIN, PHYSICAL DISCOMFORT IN THE FORM OF THE HIP FEELING LIKE IT WAS GOING OUT OF THE SOCKET, CONSTANT AUDIBLE POPPING SOUNDS; WORSENING OF THE CONDITION IN THE LEFT HIP WHEN ENGAGING IN ANY PHYSICAL ACTIVITY AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2012 - PATIENT FACT SHEET WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS MECHANICAL FAILURE, LEFT TOTAL HIP ARTHROPLASTY. OPERATIVE FINDING REPORTED AMOUNTS OF BOTH HETEROTOPIC OSSIFICATION AS WELL AS METALOSIS WITH CHRONIC INFLAMMATION AND BURSITIS. REVISION NOTE REPORTED SOME METALOSIS DETECTED AROUND THE HEAD-NECK JUNCTION AND DEEPER AROUND THE PERIARTICULAR AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 52 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL LTD. 8010379 2815289

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other