BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2870323 · Received December 12, 2012

    Report

    Report Number
    1818910-2012-28710
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    September 12, 2018
    Report Date
    August 15, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED SEVERE PAIN, DISABILITY, PHYSICAL IMPAIRMENT, DISFIGUREMENT, AGGRAVATION OF A PRE-EXISTING CONDITION AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN, METALLOSIS AND ELEVATED METAL ION LEVELS. REVISION NOTES REPORTED THAT THERE WERE SCAR TISSUES, SOME HETEROTOPIC OSSIFICATION, OBVIOUS METAL STAINING WITH DARK STAINING OF THE SYNOVIAL TISSUES, DIFFUSE SYNOVITIS WITH STAINING FROM METALLOSIS, SOME MILD BLACK CORROSIVE CHANGES AT THE TAPER, FIBROUS INGROWTH OVER THE MAJORITY OF THE SHELL, AND ONLY 10% BONY INGROWTH SUPERIORLY AT THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL LTD - 8010379 2783676

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other