BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL BUSHING

    MDR report key: 7084280 · Received December 5, 2017

    Report

    Report Number
    0001825034-2017-10846
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    February 9, 2010
    Report Date
    February 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS - OSS RS SEGENTAL FEMORAL #: 161011, LOT #: 754040. OSS DCM POLYETHYLENE TIBIAL BEARING #: 150414 LOT, #: 328940. OSS LOCKING PIN #: 150478 ,LOT #: 015620. OSS TM YOKE #: 150493, LOT #: 532330. OSS RS FEMORAL BUSHING #: 161034 LOT #: 786860. OSS RS AXLE #: 161035, LOT #: 273200. OSS NON-MOD TIB PLATE LONG #: 150420, LOT #: 716230. OSS DIAPHYSEAL SEGMENT #: 150465, LOT #: 845630. OSS SEGMENTAL STACKING ADAPTER # :150483, LOT #:012900. CPS ANCHOR PLUG #: 178400, LOT #: 081840. CPS NUT CO-CR-MO ALLOY #: 178512, LOT #: 084090. CPS TRANSVERSE PIN #: 178526, LOT #:812230. CPS/OSS TPR ADAPT W/OSS SC #: 178711, LOT #: 928770. COBALT-G HV BONE CEMENT #: 402433, LOT #: 703160. OPTIVAC KIT DOUBLE MIX #: 417200, LOT #: 341879. CPS SPINDLE COLLAR #: CP112678, LOT #: 638250. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-10843, 0001825034-2017-10845, 0001825034-2017-10847, 0001825034-2017-10848, 0001825034-2017-10849 AND 0001825034-2017-10850. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-10843-1, 0001825034-2017-10845-1, 0001825034-2017-10847-1, 0001825034-2017-10848-1, 0001825034-2017-10849-1 AND 0001825034-2017-10850-1. 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. 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

    THE PATIENT UNDERWENT A REVISION PROCEDURE 2 YEARS 2 MONTHS POST INITIAL SURGERY DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864697 OSS TIBIAL BUSHING PROSTHESIS HIP JDI ZIMMER BIOMET, INC. N/A 947960

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R SEE H10