BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3012372 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-03433
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    May 23, 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
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME. UPDATE: (B)(4) 2013 - PPD RECEIVED. PART/LOT INFORMATION HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. 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

    THIS IS A DUPLICATE REPORT OF 1818910-2013-18270. THIS REPORT, 1818910-2013-03433, WILL BE KEPT FOR INVESTIGATIONAL PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2013-18270. DEPUY STILL CONSIDERS THIS COMPLAINT 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. 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.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013-SALES REP REPORTED PATIENT UNDERWENT REVISION PROCEDURE OF RIGHT HIP. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, SCARRING AND DISFIGUREMENT; METAL POISONING AND METALLOSIS DUE TO METAL DEBRIS; ELEVATED COBALT LEVEL AND FLUID POCKETS AROUND HIP AFTER ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116088 ASR UNI FEMORAL IMPL SIZE 49 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2791091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other