BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 50ODX44ID

    MDR report key: 12015457 · Received June 17, 2021

    Report

    Report Number
    0001825034-2021-01828
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    October 26, 2018
    Report Date
    September 10, 2021
    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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PRESENTED WITH PAIN AND DISABILITY, WORK UP NEGATIVE FOR INFECTION, METAL IONS WERE ELEVATED CULTURES X 2, FLUID AND TISSUE SENT FOR CULTURE AND SENSITIVITY. 'TWENTY ML OF A GREEN, YELLOW TINGED CLOUDY FLUID WERE ASPIRATED. THERE WAS NO APPEARANCE OF PURULENCE, BUT THIS WAS CONSISTENT WITH A METALLOSIS APPEARANCE. THE APPEARANCE OF THE TISSUE ONCE AGAIN WAS CONSISTENT WITH METALLOSIS FOREIGN BODY TYPE REACTION.' STEM AND SHELL WERE WELL FIXED AND REMAINED IN PLACE, NO COMPLICATIONS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART: 157444, LOT: 604070. PART: 604070, LOT: 617600. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01829 0001825034-2021-01830

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY EIGHT YEARS AND EIGHT MONTHS POST-IMPLANTATION DUE TO PAIN, DIFFICULTY AMBULATION AND INCREASE METAL ION LEVELS. THE HEAD WAS REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914053 M2A-MAGNUM PF CUP 50ODX44ID PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 271310

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R SEE H10.