BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS SEGMENTAL STACKING ADAPTER

    MDR report key: 8930364 · Received August 26, 2019

    Report

    Report Number
    0001825034-2019-03698
    Event Type
    Injury
    Date Received
    August 26, 2019
    Report Date
    December 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K011455
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES OR MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY RECORD (DHR) 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03697. CONCOMITANT MEDICAL PRODUCTS: MOD ARTHRO 0 DEG LCK COLLAR, CATALOG#: CP260600, LOT#: 491090; CPS LG SPDL WITH PINS 800LBF, CATALOG#: 178358, LOT#: 502600; CPS ANCHOR PLUG 14MM, CATALOG#: 178404, LOT#: 213070; CPS TRANSVERSE PIN 6PK 32MM, CATALOG#: 178527, LOT#: 134880; CPS CENTERING SLEEVE 18MM, CATALOG#: 178540, LOT#: 131070; CPS NUT CO-CR-MO ALLOY, CATALOG#: 178512, LOT#: 498690; CPS ANCHOR PLUG 10MM, CATALOG#: 178400, LOT#: 182490; CPS SM SPDL WITH PINS 800LBF, CATALOG#: 178355, LOT#: 717020; CPS/OSS 5CM TPR ADAPT W/OSS SC, CATALOG#: 178711, LOT#: 433100; CPS NUT CO-CR-MO ALLOY, CATALOG#: 178512, LOT#: 222820; CPS TRANSVERSE PIN 6PK 32MM, CATALOG#: 178527, LOT#: 742300; CPS CENTERING SLEEVE 15MM, CATALOG#: 178537, LOT#: 935290; CPS/OSS 5CM TPR ADAPT W/OSS, SC CATALOG#: 178711, LOT#: 250750; MOD ARTHRO NL 3CM DIASL CNCTR, CATALOG#: CP260607, LOT#: 580090; MOD ARTHRO NL 3CM DIASL CNCTR, CATALOG#: CP260607, LOT#: 181570; OSS 4CM DIAPHYSEAL SEGMENT, CATALOG#: 150482, LOT#: 801580. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724243 OSS SEGMENTAL STACKING ADAPTER PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 580530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R