BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2800356 · Received October 22, 2012

    Report

    Report Number
    1818910-2012-76394
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    March 8, 2012
    Report Date
    October 4, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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.

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF THE MEDICAL RECORDS, IT HAS BEEN DETERMINED THAT THIS PRODUCT HAS BEEN REPORTED TWICE. THIS DUPLICATION IS AN ERROR. THIS REPORT WILL BE REJECTED.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2012 - PATIENT FACT SHEET WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES DIMINISHED PHYSICAL FUNCTION, PAIN, IMPAIRMENT, LIMITED RANGE OF MOTION AND ELVEVATED LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE: 19 OCT 2017. PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THERE IS NO NEW INFORMATION. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON OCT 27, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2838965

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention