BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS

    MDR report key: 7278322 · Received February 16, 2018

    Report

    Report Number
    0001822565-2018-00966
    Event Type
    Injury
    Date Received
    February 16, 2018
    Date of Event
    February 24, 2017
    Report Date
    March 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    PK142157
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED REPORT(S): 0001822565 - 2018 - 00965. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ECHO FX 7MM STD FEMORAL CAT: 12-151307 LOT: 697250, 28MM MOD HD STD NECK TP1 TAPER CAT: 163662 LOT: 326480, RINGLOC BI-POLAR 28X46MM CAT: 11-165216 LOT: 444440, INGL ANSR IMPCT DSTL PSTNR 10 CAT: 162640 LOT: 786980. 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

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO INFECTION. THERE WERE NO COMPLICATIONS OR DELAYS REPORTED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120220 PALACOS BONE CEMENT LOD ZIMMER BIOMET, INC. N/A 81494445

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R 00111314001 PALACOS CEMENT, LOT 81494445