BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2232200 · Received September 2, 2011

    Report

    Report Number
    1818910-2011-17023
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    November 4, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: IN (B)(6) 2009, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP. FOLLOWING HER SURGERY, PATIENT BEGAN SUFFERING FROM DISCOMFORT AND PAIN IN HER HIP, WAS TAKING NUMEROUS PAIN MEDICATIONS, HAD ELEVATED COBALT LEVELS, AND HER PHYSICIAN CONCLUDED THAT HER ASR HIP NEEDED TO BE REPLACED. IN (B)(6) 2011, PATIENT UNDERWENT PARTIAL REVISION SURGERY TO REMOVE A FAILED PORTION OF HER ASR HIP AND REPLACE IT WITH ANOTHER PORTION. PATIENT IS CURRENTLY STILL EXPERIENCING PAIN AND RECUPERATING FROM HER REVISION SURGERY.

    Description of Event or Problem · 1

    UPDATE REC¿D (B)(6) 2013 ¿ MEDICAL RECORDS WERE RECEIVED. REVISION OPERATIVE REPORTS INDICATES THE FOLLOWING: LOOSENING OF PROSTHESIS; PAIN; BROWNISH YELLOW FLUID; CASEATING MATERIAL; MILD SYNOVITIS; ABNORMAL SOFT TISSUE; WITH MINIMAL RELEASE, THE CUP WAS ABLE TO BE FREE AND EXTRICATED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2969525

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention