BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPLANT SIZE 41

    MDR report key: 2250586 · Received September 16, 2011

    Report

    Report Number
    1818910-2011-18203
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    February 28, 2011
    Report Date
    August 18, 2011
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: PATIENT WAS REVISED TO ADDRESS GROIN PAIN DUE TO CUP LOOSENING. DOI UNK - DOR (B)(6) 2011. 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

    PATIENT FACT SHEET (PFS) FORM AND IMPLANT STICKERS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION AND PATIENTS DATE OF BIRTH AND . THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL 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

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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

    PATIENT WAS REVISED TO ADDRESS GROIN PAIN DUE TO CUP LOOSENING. UPDATE: (B)(6) 2011 - LITIGATION PAPERS RECEIVED. THEY ALLEGE THAT PATIENT SUFFERED FROM METALLOSIS AND THAT THERE WAS A COPIOUS AMOUNT OF BROWNISH-GRAYISH MATERIAL FOUND ONCE THE CAPSULE WAS ENTERED. THE OPERATIVE NOTE INDICATES THAT THERE WAS MARKED SYNOVITIS THROUGHOUT THE ACETABULUM. DOI WAS (B)(6) 2008. REOPENED TO ADD FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPLANT SIZE 41 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2341523

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention