BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2850005 · Received November 29, 2012

    Report

    Report Number
    1818910-2012-28411
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 18, 2012
    Report Date
    November 14, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS WHICH NEGATIVELY AFFECTED MOBILITY, TOXICITY OF METAL IN BODY, AND ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAVE BEEN LIMITED AFTER ASR HIP IMPLANT. DEPUY STILL 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

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO FAILED ASR HIP REPLACEMENT. RECORDS INDICATE THE PATIENT A LARGE AMOUNT OF TURBID FLUID, DEBRIS, AND ABNORMAL SOFT TISSUE WAS FOUND IN THE SOCKET. THE ACETABULAR COMPONENT WAS NOT GROSSLY LOOSE BUT WAS NOT SOLIDLY INGROWN. **UPDATE** (B)(4) 2013 - LITIGATION RECEIVED 04/30/2013 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. LITIGATION ALLEGES PATIENT HAD PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS WHICH NEGATIVELY AFFECTED MOBILITY, TOXICITY OF METAL IN BODY AND ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAVE BEEN LIMITED AFTER ASR HIP IMPLANT. LITIGATION ALSO MENTIONS THE TURBID FLUID, DEBRIS AND SOFT TISSUE INDICATED IN THE MEDICAL RECORDS AS STATED ABOVE. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. **UPDATE** (B)(4) 2013 - PLAINTIFF¿S 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

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO FAILED ASR HIP REPLACEMENT. RECORDS INDICATE THE PATIENT A LARGE AMOUNT OF TURBID FLUID, DEBRIS, AND ABNORMAL SOFT TISSUE WAS FOUND IN THE SOCKET. THE ACETABULAR COMPONENT WAS NOT GROSSLY LOOSE BUT WAS NOT SOLIDLY INGROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 HEAD KWA DEPUY INTERNATIONAL 2144018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention