BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 9362420 · Received November 22, 2019

    Report

    Report Number
    0001825034-2019-05320
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    July 5, 2016
    Report Date
    December 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE M2A-MAGNUM MOD HD SZ 50MM AND ONE M2A-MAGNUM PF CUP 56ODX50ID WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THERE WAS STILL BIO MATERIAL ON THE OUTSIDE OF THE CUP. THE TAPER OF THE HEAD HAS A BLACK LINE AROUND THE INSIDE. THE OUTSIDE RADIUS OF THE HEAD SHOWS VISIBLE SCUFFING. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION 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.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING CLEAR BROWN FLUID. METALLOSIS AND THIN-WALLED PSEUDOTUMOR TYPE PRESENTATION ALONG GREATER TROCHANTERIC BURSAL REGION DOWN TO THE POSTERIOR CAPSULE. DESTRUCTION OF THE CENTRAL HALF OF THE GLUTEUS MEDIUS ATTACHMENT TO THE GREATER TROCHANTER CONSISTENT WITH MILD METAL-ON-METAL HYPERSENSITIVITY REACTION. THE CUP APPEARED VERTICAL. DHR WAS REVIEWED AND NO DISCREPANCIES 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 · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 157450 ¿ M2A MAGNUM HEAD ¿ 231430, US157856 ¿ M2A MAGNUM CUP ¿ 667860, 139258 ¿ M2A MAGNUM TAPER - 267030, X181313 ¿ BIMETRIC FEMORAL STEM ¿ 750440. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. 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 -05319, 0001825034 -2016 -03067.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, METALLOSIS AND THIN-WALLED PSEUDOTUMOR TYPE PRESENTATION WHICH EXTENDED FROM THE GREAT TROCHANTERIC BURSAL REGION DOWN INTO THE POSTERIOR CAPSULE TO THE JOINT. THERE WAS ALSO NOTED TISSUE DAMAGE AND DESTRUCTION OF THE CENTRAL HALF OF THE GLUTEUS MEDIUS ATTACHMENT TO THE GREATER TROCHANTER AND THE CUP APPEARED VERTICAL. 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
    1157624 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 667860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R