BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 46

    MDR report key: 2243431 · Received September 12, 2011

    Report

    Report Number
    1818910-2011-17777
    Event Type
    Injury
    Date Received
    September 12, 2011
    Report Date
    October 1, 2013
    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
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    BILATERAL PATIENT - RIGHT SIDE REPORTED UNDER ANOTHER COMPLAINT. LITIGATION PAPERS ALLEGE THE FOLLOWING: IN (B)(6) 2006, PATIENT UNDERWENT A SURGICAL PROCEDURE TO IMPLANT AN ASR HIP IN HER LEFT SIDE. IN (B)(6) 2006, PATIENT UNDERWENT A SURGICAL PROCEDURE TO IMPLANT AN ASR HIP IN HER RIGHT SIDE. IN APPROXIMATELY (B)(6) 2009, PATIENT BEGAN EXPERIENCING SYMPTOMS, INCLUDING BUT NOT LIMITED TO, DISCOMFORT, SQUEAKING, PAIN, AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED HER ABILITY TO WALK, MOVE, AND SLEEP. PATIENTS ORTHOPEDIC SURGEON, INVESTIGATED HER SYMPTOMS AND IN APPROXIMATELY (B)(6) 2009 CONCLUDED THAT THE PROBLEMS WERE STEMMING FROM THE ASR HIP IN HER RIGHT SIDE, AND THAT PATIENT WAS GOING TO HAVE TO UNDERGO REVISION SURGERY. RIGHT SIDE REVISED IN (B)(6), 2010. PATIENT IS AT A CONTINUED RISK BECAUSE OF THE ASR HIP STILL IN PLACE IN HER LEFT SIDE.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2013 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED BY INVOICE SEARCH. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 46 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2139978

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention