BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 3790912 · Received May 5, 2014

    Report

    Report Number
    1818910-2014-18120
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 23, 2014
    Report Date
    October 31, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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 THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPDATE REC¿D 6/11/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS FLUID COLLECTION AND ELEVATED METAL ION LEVELS. UPON REVISION, CLOUDY FLUID, FIBRINOUS TAN TISSUE WITHIN THE FEMORAL HEAD, A THICKENED CAPSULE, AND SOME BLACK CORROSION DEBRIS AT THE INFERIOR PORTION OF THE TRUNNION WERE NOTED, THOUGH THE SOURCE OF THE CORROSION DEBRIS WAS NOT GIVEN. THE STEM REMAINED IN SITU AND THE TRUNNION WAS NOTED TO BE INTACT. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 06/25/2014.

    Description of Event or Problem · 1

    UPDATE REC'D 10/31/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN AND ELEVATED METAL ION LEVELS. THE STEM IS BEING ADDED TO THE COMPLAINT. THE DOB WAS PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 11/25/2014.

    Description of Event or Problem · 1

    ASR REVISION REPORTED BY SALES REP. RIGHT.REASON FOR REVISION - PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266490 ASR ACETABULAR CUPS 60 HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. - 1818910 Y28JA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention