BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP

    MDR report key: 7020677 · Received November 10, 2017

    Report

    Report Number
    0001825034-2017-10127
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    June 6, 2016
    Report Date
    January 23, 2018
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CUP WAS NOT EXPLANTED AS VERIFIED BY PATIENT RECORDS. EVENT DATE AS CONFIRMED BY PATIENT RECORDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: P/N 139256 M2A-MAGNUM 42-50 TPR INSRT STD L/N 879290, TPRLC 133 TYPE1 PPS HO 9.0 P/N 51-104090 L/N 2624255, M2A-MAGNUM MOD HD SZ 42MM P/N 157442 L/N 200270. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF REVISION OP NOTES STATES PATIENT UNDERWENT RIGHT HIP REPLACEMENT DUE TO METALLOSIS SECONDARY TO LARGE HEAD AND OSTEOLYSIS. SURGEON ENCOUNTERED PERICAPSULAR METALLOSIS ABOUT THE SOFT TISSUE, LARGE EFFUSION, AND MILD OSTEOLYSIS NEAR FEMORAL COMPONENT. FEMORAL COMPONENT WAS VERY STABLE. A TOTAL OF 45ML OF GRAYISH ¿ APPEARING OXIDATIVE FLUID WAS ASPIRATED FROM THE RIGHT HIP INDICATING METALLOSIS. NO METALLOSIS APPEARED TO BE GENERATED AT HEAD BALL TAPER JUNCTION ON THE TRUNNION. NO DELAY OR COMPLICATIONS WERE STATED IN THE OP NOTES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT(S): 0002648920-2017-10128. 0001822565-2017- 03848.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO ELEVATED METAL ION LEVELS AND METALLOSIS. DURING THE PROCEDURE, A TOTAL OF 45 ML OF GRAYISH OXIDATIVE FLUID WAS ASPIRATED FROM THE HIP INDICATING METALLOSIS. THE PSEUDOCAPSULE WAS VERY THICKENED GRAYISH BLACK AND GREEN IN COLOR RELATED TO THE OXIDATIVE METALLOSIS AT THE JOINT. THERE WERE EARLY STAGES OF OSTEOLYSIS AROUND THE ENTIRE IMPLANT BONE JUNCTION PROXIMALLY. THE MODULAR HEAD WAS REMOVED AND REPLACED. A POLY BEARING WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798387 M2A-MAGNUM PF CUP HIP PROTHSIS KWA ZIMMER BIOMET, INC. N/A 403120

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R