BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2142907 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-11145
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    November 21, 2013
    Report Date
    February 19, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    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. (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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2007, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE. AFTER HIS SURGERY, PATIENT EXPERIENCED PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, AND HIGH LEVELS OF TOXIC METALS IN HIS BLOOD STREAM. PATIENT BELIEVES HE WILL BE REQUIRED TO UNDERGO A SURGICAL REVISION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE:ON OR ABOUT (B)(4), 2007, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE. AFTER HIS SURGERY, PATIENT EXPERIENCED PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, AND HIGH LEVELS OF TOXIC METAL IN HIS BLOOD STREAM. PATIENT BELIEVES HE WILL BE REQUIRED TO UNDERGO A SURGICAL REVISION.**UPDATE** (B)(4) 2011 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM 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

    **UPDATE** (B)(4) 2013- SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS AND PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2014 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE GRINDING AND CLICKING, CLOUDY JOINT FLUID, SYNOVITIS, AND MOSTLY FIBROUS INGROWTH ON THE CUP. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THE INFORMATION RECEIVED DOES NOT AFFECT THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD NA 2345860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention