BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS SHORT ANCHOR PLUG 10MM

    MDR report key: 8606280 · Received May 13, 2019

    Report

    Report Number
    0001825034-2019-02198
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    April 16, 2019
    Report Date
    December 18, 2019
    Manufacturer
    .
    Product Code
    JWH
    PMA / PMN Number
    K062998
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS ABLE TO BE CONFIRMED DUE TO VISUAL EVALUATION SHOWING THE ANCHOR PLUG TO BE FRACTURED. THE MEDICAL RECORDS STATED THE PATIENT WAS EXPERIENCING PAIN AND NOISE. X-RAYS SHOWED THE COMPRESS FAILED AS WELL AS DISENGAGED FROM THE PROXIMAL TIBIA. THE FRACTURED ANCHOR PLUG WAS NOTED IN THE X-RAYS AS WELL. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 178529, CPS TRANSVERSE PIN 6PK 40MM, LOT# 071000, CATALOG #: 178527, CPS TRANSVERSE PIN 6PK 32MM, LOT# 704480, CATALOG #: CP0001408, QD TIBIAL BEARING RIGHT, LOT # 618160, CATALOG #: CP0001411, SHORT COMPRESS SPINDLE 600LB, LOT # 999920, CATALOG #: CP0001428, STD CMPRS SPINDLE ELLIPT 800LB, LOT # 006230, CATALOG #: CP0001407, QD MODULAR TIBIA 63MM, LOT # 617740, CATALOG #: CP0001406, QD MOD FEM W CMPRS TPR 5CM RT, LOT # 617080, CATALOG #: CP0001410, QD KNEE AXLE, LOT # 619680, CATALOG #: CP0001409, QD TIBIAL BUSHING SET, LOT # 619540, CATALOG #: 178627, RED EXP DST FML 18CM LFT ASSY, LOT # 704480, CATALOG #: 178535, CPS CENTERING SLEEVE 13MM, LOT # 743500, CATALOG #: 178512, CPS NUT CO-CR-MO ALLOY, LOT # 071000, CATALOG #: 150483, OSS SEGMENTAL STACKING ADAPTER, LOT # 490080, CATALOG #: 151824, OSS SPIKED WASHER, LOT # 040480, CATALOG #: 178711, CPS/OSS 5CM TPR ADAPT W/OSS SC, LOT # 708770, CATALOG #: 150483, OSS SEGMENTAL STACKING ADAPTER, LOT # 975090, CATALOG #: 150469, OSS 13CM DIAPHYSEAL SEGMENT, LOT # 099780, CATALOG #: 151828, OSS 6MM SPIKED WASHER BOLT, LOT # 689330. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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: 0001825034-2019-02192, 0001825034-2019-02193.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SURGERY THE PATIENT HAD APPROXIMATELY 6 MONTHS PAIN FREE WALKING AND 2 MONTH OF GOLFING. HOWEVER, THE PAIN WORSENED AND THE PATIENT REPORTED CLICKING AND POPPING. IMAGING SHOWED A FAILED COMPRESS. WHICH HAD DISENGAGED WITH THE TIBIA THROUGH A TIBIA FRACTURE, THE ANCHOR PLUG HAD ALSO BROKEN. THIS LEAD TO THE DECISION OF AN ABOVE KNEE AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399612 CPS SHORT ANCHOR PLUG 10MM PROSTHESIS, KNEE JWH . N/A 671430

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R