BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2840849 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-24939
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    December 4, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. REF. (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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES, PATIENT HAD PAIN AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT. **UPDATE: (B)(4) 2012 PLAINTIFF FACT SHEET RECEIVED WITH PART/LOT INFORMATION. ***UPDATE: (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN, METALLOSIS AND DISCOMFORT.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO SWELLING, CLOUDY FLUID, METAL STAINING THROUGHOUT THE GREATER TROCHANTER, AND SIGNIFICANT THINNING OF THE ANTERIOR WALL AND A LOOSE PIECE OF BONE OF THE POSTERIOR WALL. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 ACETABULAR SHELL KWA DEPUY INTERNATIONAL 2168215

    Patients

    Seq Age Sex Outcome Treatment
    1 Other