BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL 9X137

    MDR report key: 9255929 · Received October 30, 2019

    Report

    Report Number
    0001825034-2019-04896
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    March 7, 2018
    Report Date
    February 26, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K830313
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. REVISION OP NOTES DEMONSTRATED THAT THE PATIENT WAS REVISED DUE TO PROSTHETIC WEAR, OSTEOLYSIS ALONG RIGHT PROXIMAL FEMUR. THE PATIENT DEVELOPED PAIN. X-RAYS HAD SHOWN CORTICAL THICKENING ALONG THE PROXIMAL SHAFT ALONG THE MID STEM. CO CR LEVEL WAS ELEVATED. MARS MRI SHOWED OSTEOLYSIS ABOUT THE STEM. THERE WAS OSTEOLYSIS RIGHT PROXIMAL FEMUR. THE BONE WAS QUITE FRAGILE ALONG THE CALCAR AREA, AND CALCAR HAD ALREADY ERODED NEARLY TO THE LESSER TROCHANTER. EXTENDED TROCHANTERIC OSTEOTOMY WAS PERFORMED TO REMOVE THE STEM. CABLE AND PLATE WAS USED TO KEEP THE TROCHANTERIC FRAGMENT IN PLACE. BROWNISH DISCOLORATION OF THE TISSUES NOTED WITH LOCAL TISSUE REACTION AND THICKENING OF THE SYNOVIAL OR BURSAL TISSUE. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157848 LOT 920380 M2A CUP 48X42MM, 157442 LOT 207660 M2A HEAD 42MM, 139254 LOT 221550 M2A TAPER ADAPTER-3MMTIME. 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 - 2019 - 04895 HEAD, 0001825034 - 2019 - 04897 CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED NINE YEARS LATER DUE TO INCREASED PAIN AND METAL ION LEVELS, AS WELL AS OSTEOLYSIS AND BONE REMODELING DIAGNOSED ON IMAGING. DURING THE REVISION, THICKENING OF THE SYNOVIAL TISSUE AND LOCAL TISSUE REACTION WAS NOTED. AN EXTENDED TROCHANTERIC OSTEOTOMY WAS PERFORMED TO REMOVE THE FEMORAL STEM, AND A TROCHANTERIC PLATE WITH WIRES WAS REQUIRED TO STABILIZE THE FIXATION DUE TO EROSION OF THE CALCAR. THE HEAD, NECK, AND STEM WERE PLACED WITHOUT FURTHER COMPLICATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048748 TAPERLOC POR FMRL 9X137 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 484280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R