BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2111536 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08566
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    May 16, 2012
    Report Date
    March 13, 2026
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED: CORRECTION/REMOVAL REPORTING NUMBER. 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.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION HAS BEEN REOPENED BECAUSE THE PATIENT HAS BEEN REVISED. DEPUY WILL NOTIFY THE FDA OF THE OUTCOME OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT ON OR ABOUT (B)(6) 2008, PATIENT HAD A DEPUY ASR HIP IMPLANTED. PATIENT HAS SUFFERED INJURY TO HIS BODY AND LIMBS. UPDATE - (B)(6) 2012 - CLINICAL REPORT STATES THAT PATIENT WAS REVISED (B)(6) 2012 DUE TO LOOSENING OF THE CUP AND STEM. UPDATE: (B)(6) 2012 - THE SALES REP HAS ALSO REPORTED THE REVISION SURGERY. REPORT STATED THAT PATIENT WAS REVISED TO ADDRESS STEM LOOSENING.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT ON OR ABOUT (B)(6) 2008, PATIENT HAD A DEPUY ASR HIP IMPLANTED. PATIENT HAS SUFFERED INJURY TO HIS BODY AND LIMBS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT ON OR ABOUT (B)(6) 2008, PATIENT HAD A DEPUY ASR HIP IMPLANTED. PATIENT HAS SUFFERED INJURY TO HIS BODY AND LIMBS. PATIENT IS A RESIDENT OF (B)(6). UPDATE - (B)(4) 2012 - CLINICAL REPORT STATES THAT PATIENT WAS REVISED (B)(6) 2012, DUE TO LOOSENING OF THE CUP AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 ACETABULAR CUP KWA DEPUY INTERNATIONAL, LTD. NA 2611811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention