BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR -6MM NECK

    MDR report key: 8101085 · Received November 26, 2018

    Report

    Report Number
    0001825034-2018-10866
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    January 10, 2013
    Report Date
    April 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K960303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. POSTOPERATIVE VISIT NOTES STATE THAT THE PATIENT WAS FOUND TO HAVE CELLULITIS ABOUT THE L HIP WOUND, AND WAS TREATED WITH ANTIBIOTICS. THE CELLULITIS CONTINUED FOR APPROXIMATELY 2 WEEKS AFTER TREATMENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO RELATED DEVIATIONS/ ANOMALIES WERE IDENTIFIED THAT AFFECT THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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). MEDICAL DEVICES: 54ODX48ID MAGNUM ABX PF CUP #US157854 LOT 072830, TAPERLOC POR RED/DIST 13.5X147 # ITEM 12-103207 LOT 534610. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10865, AND 0001825034-2018-10867. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CELLULITIS WAS NOTED ABOUT THE LEFT HIP WOUND APPROXIMATELY 2 MONTHS POST REVISION AND TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943039 32MM MOD HEAD COCR -6MM NECK PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 196450

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other