BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2860931 · Received December 6, 2012

    Report

    Report Number
    1818910-2012-27219
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    March 29, 2011
    Report Date
    October 7, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: METALLOSIS; LOOSENING OF ACETABULAR SHELL; CLOUDY GREENISH APPEARING FLUID IN HIP JOINT SPACE; LINING OF PSEUDOCAPSULE HAD DISCOLORED MEMBRANE CONSISTENT WITH METAL WEAR DEBRIS; SHELL CAME LOOSE VERY EASILY AND HAD MINIMAL BONE HEALING GROWTH; FLOOR OF THE ACETABULUM HAD FIBROUS TISSUE AND INFLAMMATORY MEMBRANE. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND ACETABULAR LOOSENING. **UPDATE** (B)(4) 2012; PATIENT FACT SHEET WAS RECEIVED, WHICH IDENTIFIED PART/LOT, BIRTHDATE AND DOI INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. **UPDATE** - (B)(4) 2012 - LITIGATION PAPERS RECEIVED (B)(4) 2012. LITIGATION ALLEGES PATIENT SUFFERED PAIN AND SUFFERING AND EXCESSIVE LEVEL OF CHROMIUM AND COBALT. FEMORAL HEAD ADDED TO COMPLAINT. **UPDATE** - (B)(4) 2012 - PATIENT FACT SHEET RECEIVED (B)(4) 2012. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2459487

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention