BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP

    MDR report key: 9985828 · Received April 22, 2020

    Report

    Report Number
    0001825034-2020-01753
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    November 22, 2017
    Report Date
    August 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G4; H2; H3; H6 REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING THAT THE PATIENT DEVELOPED PAIN AND ELEVATED METAL ION LEVELS. OSTEOLYTIC CYST WAS DEBRIDED AND FILLED WITH CANCELLOUS BONE GRAFT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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.

    Additional Manufacturer Narrative · 0

    D11: US157860 ¿ M2A MAGNUM CUP -756870; 139272 _ M2A MAGNUM TAPER ¿ 561850; 157454 ¿ M2A MAGNUM HEAD ¿ 803060; 192112 ¿ ECHO STEM - 271930. AN UPDATED INVESTIGATION IS IN PROCESS AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 7 YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED METAL ION LEVELS, OSTEOLYSIS, AND CYST. THE HEAD COMPONENT WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. THE DHR WAS UNABLE TO BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE ROOT CAUSE IS 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 - 2020 - 01758. 0001825034 - 2020 - 01759.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAS BEEN INDICATED FOR REVISION DUE TO UNKNOWN REASON; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. 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
    450601 M2A-MAGNUM PF CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 756870

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R UNKNOWN HEAD| UNKNOWN STEM| UNKNOWN HEAD| UNKNOWN STEM