BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 BM SO 9.0

    MDR report key: 7374244 · Received March 27, 2018

    Report

    Report Number
    0001825034-2018-02083
    Event Type
    Injury
    Date Received
    March 27, 2018
    Date of Event
    March 1, 2018
    Report Date
    April 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 110010243, CUP, LOT # 6135455, ITEM # 010000848, LINER, LOT # 3401495, ITEM # 6501163, FEMORAL HEAD, LOT # UNK. (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WARSAW AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) K110400.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. AS STATED IN THE X-RAY REVIEW REPORT, THE CONTRIBUTING FACTORS FOR FEMORAL STEM SUBSIDENCE INCLUDED UNDERSIZED FEMORAL STEM AND VARUS POSITION OF THE FEMORAL STEM. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED LEFT STEM SUBSIDENCE. IT IS EXPECTED THAT THE STEM WILL STABILIZE AT A LOWER POSITION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216934 TPRLC 133 MP TYPE1 BM SO 9.0 HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 3751589

    Patients

    Seq Age Sex Outcome Treatment
    1 Other