BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL

    MDR report key: 6888572 · Received September 22, 2017

    Report

    Report Number
    0001825034-2017-07317
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    August 29, 2016
    Report Date
    September 22, 2017
    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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01404. 0001825034-2017-07315. CONCOMITANT PRODUCT: M2A 38MM MOD HD+6MM NK NO SKRT CATALOG#: 11-173664 LOT#: 924460 M2A-38 CUP NON FLARED SZ 52MM CATALOG#: 15-106052 LOT#: 915420. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 7 YEARS POST PRIMARY SURGERY, DUE TO PAIN, ELEVATED LEVELS OF COBALT AND CHROMIUM AND METALLOSIS. DURING THE SURGERY, OXIDATIVE CHANGES WAS OBSERVED ON THE SURFACE OF TRUNNION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666921 TAPERLOC POR LAT FMRL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 670390

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R