BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 4090905 · Received September 15, 2014

    Report

    Report Number
    1818910-2014-28054
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    October 17, 2014
    Report Date
    January 21, 2015
    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
    CA, US
    Reporter Occupation
    ATTORNEY

    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. 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. WWCAPA (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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN, PHYSICAL INJURY, BODILY IMPAIRMENT, AND EXCESSIVE METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE REC'D 1/21/2015 - MEDICAL RECORDS RECEIVED. DOB PROVIDED. PATIENT REVISED TO ADDRESS DISCOMFORT, CREPITATION, CO 16.5, CR 20.8 AND A MASS ON AN MRI. UPON REVISION, A LARGE QUANTITY OF SYNOVIAL FLUID AND ADVERSE TISSUE REACTION WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 02/05/15.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN, PHYSICAL INJURY, BODILY IMPAIRMENT, AND EXCESSIVE METAL ION LEVELS. UPDATE 17 OCT 2014 - ASR REVISION REPORTED VIA SALES REP. ASR XL. UNKNOWN SIDE. REASON(S) FOR REVISION : ASR REVISION FOR PAIN. ADDED PATIENT AGE AND CLINICAL ID NUMBER, SURGEON AND SALES REP DETAILS, DOR AND UPDATED CUP AND HEAD AND REPORTED SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568931 ASR ACETABULAR CUPS 58 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2717768

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R