BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3709750 · Received March 28, 2014

    Report

    Report Number
    0002249697-2014-00945
    Event Type
    Injury
    Date Received
    March 28, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN 36 MM +7.5 BIOLOX HEAD. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING A PERIPROSTHETIC FRACTURE USING A BIOMET CUP AND LINER WITH A STRYKER HEAD WAS REPORTED. CONCLUSION: THE REPORTED EVENT INVOLVES REVISION AND A CRACKED CALCAR. THE PATIENT HAD A BIOMET CUP AND LINER USED WITH A STRYKER HEAD. THIS APPLICATION OF COMPETITOR PRODUCT WITH STRYKER PRODUCT IS NOT ADVISED. A REVIEW OF RECORDS INDICATED QIN 4350 WAS PACKAGED WITH THE DEVICE AT THE TIME OF MANUFACTURE. REVIEW OF THE MOST RECENT VERSION OF THE DOCUMENT, NOTED ¿DO NOT SUBSTITUTE ANOTHER MANUFACTURER¿S DEVICE FOR ANY OF THE HOWMEDICA OSTEONICS TRIDENT SYSTEM COMPONENTS BECAUSE DESIGN, MATERIAL, OR TOLERANCE DIFFERENCES MAY LEAD TO PREMATURE DEVICE AND/OR FUNCTIONAL FAILURE. COMPONENTS OF THE SYSTEM HAVE BEEN SPECIFICALLY DESIGNED TO WORK TOGETHER. ANY SUCH USE WILL NEGATE THE RESPONSIBILITY OF HOWMEDICA OSTEONICS CORP. FOR THE PERFORMANCE OF THE RESULTING MIXED COMPONENT IMPLANT.¿ BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR EXCHANGES A STRYKER 36MM +7.5 BIOLOX HEAD FOR A 40MM +12 COCR HEAD. CUP AND LINER WERE BIOMET PRODUCTS. HE EXCHANGED THE LINER IN THE BIOMET CUP. ON (B)(6) 2014, THE SALES REP INDICATED THAT THE PATIENT WAS REVISED DUE TO PAIN. DURING THE REVISION SURGERY, THE SURGEON NOTED THAT THE PATIENT HAD A CRACKED CALCAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR EXCHANGES A STRYKER 36MM +7.5 BIOLOX HEAD FOR A 40MM +12 COCR HEAD. CUP AND LINER WERE BIOMET PRODUCTS. HE EXCHANGED THE LINER IN THE BIOMET CUP. ON (B)(6) 2014, THE SALES REP INDICATED THAT THE PATIENT WAS REVISED DUE TO PAIN. DURING THE REVISION SURGERY, THE SURGEON NOTED THAT THE PATIENT HAD A CRACKED CALCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186599 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R