BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 58

    MDR report key: 3111715 · Received May 14, 2013

    Report

    Report Number
    1818910-2013-05686
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 2, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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 THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4) REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION ASR XL - LEFT REASON(S) FOR REVISION: HIGH BLOOD COBALT. BI-LATERAL PATIENT, PLEASE SEE (B)(4) FOR THE RIGHT SIDE REVISION. UPDATE ALERT DATE (B)(6) 2017. CONFIRMED THAT THIS PATIENT IS DECEASED. THE DATE OF DEATH IS (B)(6) 2017., ATTACHED SCF, ADDED ADDITIONAL REASONS FOR REVISION X 3 , ADDITIONAL SURGEON, PATIENT NAME INITIALS AND DATE OF BIRTH. TAKEN FROM EMAIL DATED (B)(6) 2017. REASONS FOR REVISION : PAIN, NOISE, ALVAL.. THIS IS A BI-LATERAL PATIENT. FOR THE RIGHT SIDE SEE (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    ASR REVISION; ASR XL - LEFT HIP; REASON FOR REVISION: HIGH LEVELS OF COBALT IN THE BLOOD OF THE PATIENT.

    Description of Event or Problem · 1

    UPDATE ALERT DATE (B)(6) 2017. ADDITIONAL REASONS FOR REVISION: PAIN, NOISE, ALVAL. CONFIRMED THAT THIS PATIENT IS DECEASED. THERE IS NO INDICATION THAT THE DEVICE CONTRIBUTED TO DEATH. THE DATE OF DEATH IS (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212034 ASR ACETABULAR IMPLANT 58 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2371722

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention