BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 39

    MDR report key: 3052996 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-04411
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 3, 2014
    Report Date
    May 27, 2014
    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
    NY, 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

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPDATE REC¿D 04/03/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, METAL STAINING AND CORROSION WERE NOTED. THE ADAPTER SLEEVE AND FEMORAL STEM ARE NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 04/24/2014. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER LEFT HIP ON OR ABOUT (B)(6) 2008. PATIENT EXPERIENCED PAIN AND SUFFERING; DISABILITY; IMPAIRMENT; LOSS OF FUNCTION, USE AND RANGE OF MOTION; DECREASED AND POOR HIP PERFORMANCE; GAIT DISTURBANCE; METALLIC AND OTHER PARTICULATE CONTAMINATION OF THE BLOOD AND BODY; EXACERBATION OF UNDERLYING HIP JOINT DISORDERS; INTERNAL SCARRING; AND IRRITATION AND INJURY TO THE TENDONS, LIGAMENTS, MUSCLES, BLOOD VESSELS, CARTILAGES, NERVES, BONES AND SOFT TISSUES OF THE HIP JOINT AND SURROUNDING AREAS. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2014 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS MECHANICAL GRINDING. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156430 ASR UNI FEMORAL IMPL SIZE 39 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 1973234

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other