BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-6

    MDR report key: 8924959 · Received August 23, 2019

    Report

    Report Number
    0001825034-2019-03762
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    July 25, 2018
    Report Date
    October 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING LEFT HIP METALLOSIS, COLD WELDED HEAD AND NECK SLEEVE, INTRAOPERATIVE FRACTURE OF THE GREATER TROCHANTER. THE FRACTURE WAS FIXED WITH PLATE AND 5 CABLES. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-103203 ¿ TAPERLOC STEM ¿ 042650, US157850 ¿ M2A MAGNUM CUP ¿ 0644600, 157444 ¿ M2A MAGNUM HEAD - 742780. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED FOR THE 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 03763.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 12 YEARS POST IMPLANTATION. DURING THE SURGERY, THE TAPER ADAPTER WAS FOUND TO BE COLD-WELDED TO THE STEM. THE APPROPRIATE EXTRACTION INSTRUMENT WAS NOT AVAILABLE SO THE SURGEON ATTEMPTED TO REMOVE THE TAPER WITHOUT AND ENDED UP DISLODGING THE STEM. THE TROCHANTER ENDED UP FRACTURING AS A RESULT. THE FRACTURE WAS FIXED WITH A TROCHANTERIC PLATE AND 5 CABLES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720859 M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 907300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R