BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 7396651 · Received April 4, 2018

    Report

    Report Number
    0001825034-2018-02290
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    March 14, 2016
    Report Date
    January 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02291 - 3, 0001825034 - 2018 - 02288 - 3.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 7.5 YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED ION LEVELS, METALLOSIS, OSTEOLYSIS OF THE ACETABULUM, AND CORROSION. OP NOTES INDICATED FLUID FILLED CYST THAT EXTENDED DOWN TO THE JOINT SPACE. LIGHTLY STAINED METALLIC DEBRIS NOTED AND EXCISED WITH DEBRIDEMENT OF GRANULOMATOUS APPEARING TISSUE AND METAL STAINING THROUGHOUT THE JOINT. IT WAS ALSO NOTED THAT THE PATIENT HAD EXTENSIVE FRETTING CORROSION OF THE TRUNNION OF THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL DEVICES: ITEM # US157848, CUP, LOT # 605110; ITEM #103204, STEM, LOT #880720; ITEM #157442, FEMORAL HEAD, LOT #206990. LEGAL NOTIFICATION. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02288, 0001825034-2018-02290, 0001825034-2018-02291

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 7.5 YEARS POST IMPLANTATION DUE TO PAIN AND TRUNNIONOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 7.5 YEARS POST IMPLANTATION DUE TO PAIN; EXTENSIVE FRETTING CORROSION OF THE TRUNNION WAS NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238387 M2A-MAGNUM 42-50MM TPR INSRT-3 HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 823380

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R