BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT STEM 13X80MM PSO-R

    MDR report key: 6595375 · Received May 26, 2017

    Report

    Report Number
    0009610576-2017-00017
    Event Type
    Injury
    Date Received
    May 26, 2017
    Report Date
    May 26, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: SCREW, CATALOG 1521-16, LOT 03094566; FEMUR 64MM, CATALOG 1521-11, LOT 00090747; TIBIA 72MM LEFT, CATALOG 1521-05, LOT 04045827; TIBIAL INSERT 14MM, CATALOG 1522-14, LOT 2005061391; TIBIAL PIN, 1520-34, LOT 04017480; CLIP, CATALOG 1520-22, LOT 05057876; STRAIGHT STEM 11.5X210MM, CATALOG 1528-12, LOT 02072635. (B)(6). THIS PRODUCT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009610576-2017-00018, 0009610576-2017-00019, 0009610576-2017-00020, 0009610576-2017-00021, 0009610576-2017-00022, 0009610576-2017-00023, AND 0009610576-2017-00024.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR A KNEE REVISION DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375549 STRAIGHT STEM 13X80MM PSO-R PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. 03044950

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention