BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTEK CEMENT RESTRICTOR

    MDR report key: 2139079 · Received June 13, 2011

    Report

    Report Number
    8043817-2011-00001
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    March 19, 2006
    Report Date
    June 1, 2011
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE FDA DID NOT INCLUDE THE CUSTOMER'S INFO. THE PART NUMBER 0180-125 WAS PROVIDED, HOWEVER, THIS IS AN INVALID MICROTEK PART NUMBER. THE REPORT ALSO INCLUDED LOT NUMBER C6160. AFTER RUNNING A LOT SHIPMENT REPORT, WE CAN ONLY ASSUME THAT THE CORRECT PART NUMBER SHOULD BE 0100-18S.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTEK CEMENT RESTRICTOR 18.5MM STERILE CEMENT RESTRICTOR LXH MICROTEK MEDICAL, INC. 0100-18S C6160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R CENTERPULSE ORTHOPEDICS INC: HIP| CENTERPULSE ORTHOPEDICS INC: METAL/POLYMER| SULZER ORTHOPEDICS: (O.R.) PROSTHESIS| CENTERPULSE ORTHOPEDICS INC: CEMENTED (JDI)| CENTERPULSE ORTHOPEDICS INC: SEMI-CONSTRAINED| CENTERPULSE ORTHOPEDICS INC: (O.R.) - PROSTHESIS| ZIMMER NATURAL HIP SYSTEM: CEMENTED (JDI)| ZIMMER NATURAL HIP SYSTEM: SEMI-CONSTRAINED| ZIMMER NATURAL HIP SYSTEM: HIP| ZIMMER NATURAL HIP SYSTEM: (O.R.) - PROSTHESIS| SULZER ORTHOPEDICS: CEMENTED (JDI)| SULZER ORTHOPEDICS: SEMI-CONSTRAINED| SULZER ORTHOPEDICS: HIP| SULZER ORTHOPEDICS: METAL/POLYMER| ZIMMER NATURAL HIP SYSTEM: METAL/POLYMER| SURGICAL SIMPLEX: (O.R.) - BONE CEMENT (LOD)