BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 3150830 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-05509
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    January 11, 2013
    Report Date
    September 20, 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
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: MINIMAL AMOUNT OF FLUID WHICH WAS NORMAL IN APPEARANCE. THERE WAS NO OBVIOUS DAMAGE TO SOFT TISSUES OR BONE BUT THERE WAS HYPERTROPHIC AND AVASCULAR AND PSEUDOCAPSULE. THERE WAS NO SIGN OF ANY OSSEOINTEGRATION OF THE ACETABULAR COMPONENT. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE ON OR ABOUT (B)(6) 2006. SHE LATER EXPERIENCED PAIN AND ELEVATED LEVELS OF COBALT AND CHROMIUM. SHE HAS NOT YET SCHEDULED AN EXPLANTATION OF THE RIGHT ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251001 ASR UNI FEMORAL IMPL SIZE 53 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 1969581

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other