BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 4.0

    MDR report key: 7136865 · Received December 20, 2017

    Report

    Report Number
    0001822565-2017-08553
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    March 23, 2016
    Report Date
    December 15, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK120030
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ON INITIAL INFORMATION AND INVESTIGATION RESULTS. CONCOMITANT MEDICAL PRODUCTS: RNGLC+ LTD HOLE SHELL SZ54 CATALOG#: 16-116054 LOT#: 776420, EPOLY 36MM RLC LNR MROM SZ24 CATALOG#: EP-105994 LOT#: 444390, 36MM COCR MOD HD STD CATALOG#: 11-363662 LOT#: 590370, TI LOW PROFILE SCREW 6.5X30MM CATALOG#: 103533 LOT#: 374330. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. REVIEW OF OP NOTES STATES THAT THE FEMUR WAS GROSSLY LOOSE AND THE ENTIRE COMPONENTS WERE TAKEN OUT OF THE FEMUR WITHOUT EVEN BEING ABLE TO INDEPENDENTLY DISLODGE THE HEAD FROM THE SHAFT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. REVIEW OF THE STERILE CERTIFICATE SHOW NO DEVIATIONS OR ANOMALIES IN THE STERILIZATION PROCESS. PRODUCT LEFT ZIMMER BIOMET STERILE. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 UNDERWENT A LEFT HIP REVISION SURGERY APPROXIMATELY 15 MONTH POST PRIMARY SURGERY, DUE TO INFECTION. DURING THE REVISION, THE STEM WAS FOUND TO BE LOOSE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913296 TPRLC 133 MP TYPE1 PPS SO 4.0 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 3317341

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R