BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 48

    MDR report key: 2071697 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06369
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K073413
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: PATIENT WAS REVISED TO ADDRESS CUP LOOSENING. THE CUP MIGRATED THROUGH THE MEDIAL WALL. DOI: UNK - DOR: (B)(6) 2011 (LEFT SIDE). 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. THE REPORT STATES: PATIENT WAS REVISED TO ADDRESS CUP LOOSENING. THE CUP MIGRATED THROUGH THE MEDIAL WALL. DOI: UNK - DOR: (B)(6) 2011 (LEFT SIDE). 64) 2011 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. DOI OF (B)(6) 2009 IDENTIFIED IN LITIGATION PAPERS AND ADDED TO COMPLAINT. PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(6) 2011 - MEDICAL RECORDS RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT A PIECE OF HOST TISSUE LINING THE JOINT WAS RESECTED AND IT HAD A BLACKENED APPEARANCE SUGGESTIVE OF METALLOSIS. THE FEMORAL HEAD WAS ADDED TO THE COMPLAINT. PART/LOT NUMBERS IDENTIFIED WITH INVOICE SEARCH.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS CUP LOOSENING. THE CUP MIGRATED THROUGH THE MEDIAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 48 87KWA KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention