BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 3822277 · Received May 20, 2014

    Report

    Report Number
    1818910-2014-19162
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    March 10, 2014
    Report Date
    May 21, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. 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 REC¿D 05/21/2014- PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WITH MEDICAL RECORDS WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FROM PATIENT STICKER SHEET. MEDIAL RECORDS INDICATE UPON REVISION, CLEAR YELLOW JOINT FLUID, METALLOSIS DEBRIS, AND A LARGE CYST WERE NOTED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THE INFORMATION RECEIVED DOES NOT AFFECT THE MDR DECISION. THE COMPLAINT WAS UPDATED ON: 06/11/2014.

    Description of Event or Problem · 1

    SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS GRINDING. THE TRILOCK STEM BECAME LOOSE DURING THE SURGERY AND WAS ALSO REMOVED. UPDATE REC¿D (B)(6) 2014 - LEGAL CLAIM WAS RECEIVED, WHICH IDENTIFIED DOI INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE REC¿D (B)(6) 2014 - LITIGATION RECEIVED. LITIGATION ALLEGES INJURY, PAIN, AND ELEVATED METAL ION LEVELS. THE CUP AND FEMORAL HEAD ARE NOW REPORTABLE. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300798 ASR ACETABULAR CUPS 50 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2756158

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention