BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL LAT 13.5X147

    MDR report key: 7980472 · Received October 18, 2018

    Report

    Report Number
    0001825034-2018-09822
    Event Type
    Injury
    Date Received
    October 18, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 11-173663, M2A 38MM MOD HD, LOT # 740110. ITEM # 15-106056, M2A-38 CUP, LOT # 541500. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09800, 0001825034-2018-09801.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AND DIFFICULTY WALKING APPROXIMATELY 14 YEARS POST IMPLANTATION OF MOM DEVICES. THE PATIENT HAS BEEN INDICATED FOR A REVISION, HOWEVER, NO REVISION HAS BEEN SCHEDULED TO DATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AND DIFFICULTY WALKING APPROXIMATELY 14 YEARS POST IMPLANTATION OF MOM DEVICES. THE PATIENT HAS BEEN INDICATED FOR A REVISION; HOWEVER, NO REVISION HAS BEEN SCHEDULED TO DATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820105 TAPERLOC POR FMRL LAT 13.5X147 HIP PROSTHESIS LPH ZIMMER BIOMET, INC. N/A 357250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention