BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUP 54

    MDR report key: 2992736 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-02958
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PPD RECEIVED. PART/LOT HAS BEEN UPDATED FOR THE LEFT AND RIGHT HIPS. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    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). 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

    (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN AND DISCOMFORT; AND IT BECAME INCREASINGLY PAINFUL TO WALK, MOVE AND RISE FROM A SEATED POSITION AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE RECEIVED 05/12/2016. THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS RISING METAL ION LEVELS. UPDATED THE HEAD/CUP AND ADDED THE SLEEVE/STEM. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. COMPLAINT WAS UPDATED ON 05/25/2016.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN AND DISCOMFORT; AND IT BECAME INCREASINGLY PAINFUL TO WALK, MOVE AND RISE FROM A SEATED POSITION AFTER ASR HIP IMPLANT. UPDATE (B)(4) 2013 LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, PERMANENT PHYSICAL INJURY, DISFIGUREMENT, AND OTHER INJURIES ASSOCIATED WITH EXCESSIVE BLOOD LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96665 ASR ACETABULAR CUP 54 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2441537

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other