BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM 42-50M TPR INSRT +6

    MDR report key: 10585655 · Received September 25, 2020

    Report

    Report Number
    0001825034-2020-03596
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    May 11, 2020
    Report Date
    April 4, 2022
    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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; G4; H2; H3; H4; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PAIN WHICH INTERFERED WITH ACTIVITIES OF DAILY LIVING. ELEVATED COBALT AND CHROMIUM. MRI SHOWED PSEUDOTUMOR. X-RAY SHOWS LYSIS AROUND FEMORAL AND ACETABULAR COMPONENTS. SIGNIFICANT AMOUNT OF FRIABLE GRAYISH/BROWN TISSUE CONSISTENT WITH METALLOSIS WAS ENCOUNTERED AND SENT FOR ANALYSIS. REMOVAL OF THE FEMORAL HEAD WAS DIFFICULT AND TOOK REPEATED ATTEMPTS. FEMORAL COMPONENT WAS WELL FIXED DESPITE CONCERN ON X-RAY FOR LYSIS. ATTEMPT MADE TO EXTRACT HOWEVER STEM REMAINED WELL FIXED AND WAS LEFT IN PLACE. ATTEMPT ALSO MADE TO REMOVE ACETABULAR COMPONENT, HOWEVER REMAINED WELL FIXED. 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.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE TAPER WAS DETERMINED TO BE NOT REPORTABLE AS THE DEVICE IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE TAPER WAS DETERMINED TO BE NOT REPORTABLE AS THE DEVICE IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: CAT# 192110 ECHO POR FMRL LAT NC 10X130MM LOT# 146930; CAT# 157440 M2A-MAGNUM MOD HD SZ 40MM LOT# 946000; CAT#US157854 M2A-MAGNUM PF CUP 54ODX48ID LOT#091380. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE LOCATION IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03595, 0001825034 - 2020 - 03597, 0001825034 - 2020 - 03606.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO METALLOSIS, PAIN THAT INTERFERED WITH ACTIVITIES OF DAILY LIVING, AND OSTEOLYSIS. DURING THE PROCEDURE, THE SURGEON NOTED THE FOLLOWING: ELEVATED COBALT AND CHROMIUM LEVELS, DIFFICULTY REMOVING THE HEAD, AND FEMORAL STEM AND ACETABULAR CUP WERE WELL FIXED. THE STEM AND CUP WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052897 M2A MAGNUM 42-50M TPR INSRT +6 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 348150

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE.