BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 8239324 · Received January 11, 2019

    Report

    Report Number
    0001825034-2019-00125
    Event Type
    Injury
    Date Received
    January 11, 2019
    Date of Event
    September 14, 2017
    Report Date
    March 19, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES PROVIDED CONFIRMING PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN, METALLOSIS, AND ELEVATED METAL ION LEVELS. DHR 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 · 0

    IT WAS REPORTED THAT PATIENT PRESENTED WITH ACUTE HIP PAIN APPROXIMATELY 7 YEARS POST IMPLANTATION AND UNDERWENT A REVISION SURGERY. DURING THE SURGERY, LARGE AMOUNTS OF CLEAR FLUID, SEVERE SYNOVITIS AND WEAR DEBRIS WAS FOUND IN THE JOINT CAPSULE. THE CUP COMPONENT WAS FOUND TO BE COMPLETELY LOOSE. THE JOINT SPACE WAS DEBRIDED REMOVING PSEUDOCAPSULE AND SYNOVIAL TISSUE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS: 192014 - ECHO POR FMRL ¿ 020010. 139252 - M2A-MAGNUM 42-50MM ¿ 850450. 157446 - M2A-MAGNUM MOD HD ¿ 201370. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03542.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY 7 YEARS POST IMPLANTATION DUE TO METALLIC-STAINED TISSUE, METALLOSIS, DEHISCENCE OF THE POSTERIOR HIP IMPLANT CAPSULE, ELEVATED METAL ION LEVELS, AND LOOSENING OF THE CUP. 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
    33210 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 733430

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R