BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM - TIBIAL POLY BEARING 16MM

    MDR report key: 6959114 · Received October 18, 2017

    Report

    Report Number
    0001825034-2017-09127
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    May 26, 2010
    Report Date
    October 18, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07364, 0001825034-2017-07362, 0001825034-2017-07363, 0001825034-2017-09112, 0001825034-2017-09121, 0001825034-2017-09126, 0001825034-2017-09127. CONCOMITANT: OSS 7CM SEGMENTAL FEMORAL RT CATALOG# 150354 LOT#598100, OSS AXLE CATALOG# 150480 LOT#378790, OSS REINFORCED YOKE CATALOG#150493 LOT# 378820, OSS POLY LOCK PIN CATALOG# 150478 LOT#445140, OSS POLY FEMORAL BUSHINGS 2PK CATALOG# 150477 LOT#562430, OSS POLY TIBIAL BUSHING CATALOG#150476 LOT# 931350, OSS-K 79 MOD POROUS TI CATALOG# CP102516 LOT# 809280, CPS ANCHOR PLUG 12MM CATALOG# 178402 LOT#020450, CPS TRANSVERSE PIN 6PK 32MM CATALOG# 178527 LOT# 547720, CPS CENTERING SLEEVE 14MM CATALOG# 178536 LOT#708980, CPS SM M-H F SPINDLE 12MM PCHA CATALOG#178472 LOT# 433020, CPS NUT CO-CR-MO ALLOY CATALOG # 178512 LOT# 746180, CPS TAPER LOCKING CAP / OSS SC CATALOG#178710 LOT# 538280, CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG# 178711 LOT# 632260. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 PATIENT WAS REVISED SEVEN MONTHS AFTER INITIAL KNEE PROCEDURE DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739701 ONCOLOGY SALVAGE SYSTEM - TIBIAL POLY BEARING 16MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. 672390

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention