BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10 NARRATIVE

    MDR report key: 8806993 · Received July 19, 2019

    Report

    Report Number
    0001822565-2019-03086
    Event Type
    Injury
    Date Received
    July 19, 2019
    Report Date
    December 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). BRAND NAME: LINER NEUTRAL 32 MM I.D. SIZE GG FOR USE WITH 48 MM O.D. SIZE GG SHELL. CONCOMITANT MEDICAL PRODUCTS: 00875704801, SHELL WITH CLUSTER HOLES POROUS 48 MM, 61442349. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-03085, SHELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY IS HAS BEEN EXPERIENCING AN ITCHING SENSATION, PAIN AND SWELLING SINCE HER PROCEDURE. SURGEON THINKS SHE MAY BE HAVING AN ALLERGIC REACTION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602442 SEE H10 NARRATIVE PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 61475494

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10 NARRATIVE