BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 3771702 · Received April 24, 2014

    Report

    Report Number
    1818910-2014-17472
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 4, 2014
    Report Date
    September 5, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    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.THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN 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 THIS 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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    UPDATE REC'D 06/03/2014 - LEGAL CLAIM WAS RECEIVED, WHICH IDENTIFIED DOI & DOB INFORMATION. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 06/22/2014.

    Description of Event or Problem · 1

    SALES REP REPORTED REVISION SURGERY. PATIENT HAS BEEN REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. USED MEDICAL DEVICE DECLARATION WAS ALSO RECEIVED PROVIDING PART/LOT FOR THE FEMORAL HEAD.

    Description of Event or Problem · 1

    UPDATE REC'D 9/5/2014 - PPD WITH MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION PROVIDED. UPON REVISION, FLUID AND METALLOSIS WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 09/17/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249978 ASR ACETABULAR CUPS 58 HIP ACETABULAR CUP KWA DEPUY INTL., LTD - 8010379 2628480

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention