BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MOD HEAD

    MDR report key: 9069216 · Received September 16, 2019

    Report

    Report Number
    0001825034-2019-04098
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    December 11, 2018
    Report Date
    March 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE M2A 38MM MOD HD -3MM WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE HEAD HAS SCUFFING AND A WEAR LINE ON THE OUTSIDE DIAMETER. THERE IS ALSO BLACK DEBRIS INSIDE OF THE TAPER. 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 WITH MEDICAL RECORDS PROVIDED. OPERATIVE NOTES SHOWED ALTR. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04128 0001825034 - 2019 - 04098 0001825034 - 2020 - 00762.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BILATERAL PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY UNDERWENT A REVISION PROCEDURE APPROXIMATELY 9 YEARS LATER DUE TO PAIN, ELEVATED METAL ION LEVELS, ALTR, AND METALLOSIS. MRI SHOWED A POCKET OF FLUID AROUND THE HIP, WHICH IS AN ONGOING ISSUE RELATED TO TISSUE DAMAGE FROM METALLOSIS, HOWEVER, PT REMAINS ASYMPTOMATIC AND WITHOUT FURTHER INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BILATERAL PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 12 YEARS LATER DUE TO ELEVATED METAL ION LEVELS. MRI SHOWED A POCKET OF FLUID AROUND THE HIP. PATIENT INDICATED THE SURGEON GAVE HIM A BALL AFTER THE PROCEDURE. AT THIS TIME IT IS UNKNOWN IF ALL DEVICES WERE REMOVED OR JUST THE BALL. HE INDICATED A CERAMIC SYSTEM WAS USED TO REPLACE WHAT THEY REMOVED. 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
    867936 M2A MOD HEAD PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 915960
    867945 M2A MOD HEAD PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 915960

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R BIOMET M2A CUP CAT#15-106054 LOT#335240| BIOMET STEM CAT#12-103208 LOT#177510| UNKNOWN CUP| UNKNOWN LINER| UNKNOWN STEM