BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL 13.5X147

    MDR report key: 7348627 · Received March 19, 2018

    Report

    Report Number
    0001825034-2018-01729
    Event Type
    Injury
    Date Received
    March 19, 2018
    Report Date
    June 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO PAIN/FEMUR FRACTURE AND LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN DATE IN (B)(6) 2015. CONCOMITANT MEDICAL PRODUCTS: 11-173661, M2A 38MM MOD HD -3MM NK, 603760, 15-106056, M2A-38 CUP NON FLARED SZ 56MM, 952330. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034 - 2018 - 01728, 0001825034 - 2018 - 01727.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192335 TAPERLOC POR FMRL 13.5X147 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 109310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R