BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 11731241 · Received April 27, 2021

    Report

    Report Number
    0001825034-2021-01169
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    December 30, 2020
    Report Date
    August 31, 2021
    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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PSEUDOTUMOR RIGHT HIP, ELEVATED METAL IONS, 60% TEAR GLUTEUS MEDIUS TENDON. PRESENTED WITH INCREASED PAIN, SOFT TISSUE MASS/EFFUSION, ELEVATED COBALT AND CHROMIUM, ESR 48, CRP 1.4, SYNOVASURE AND BIOPSIES NEGATIVE FOR INFECTION. TRUNNION WAS WITHOUT CORROSION. SCAR TISSUE EXCISED, SHELL AND FEMORAL COMPONENT WELL-FIXED AND LEFT INTACT. HEAD/NECK EXCHANGED WITHOUT COMPLICATION 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 - 2021 - 02496.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: ITEM NUMBER 166316 ITEM NAME PROGRESSIVE POR FMRL10X130 RT LOT # 902170. ITEM NUMBER US157852 ITEM NAME M2A-MAGNUM PF CUP52ODX46ID LOT # 515350. ITEM NUMBER 139256 ITEM NAME M2A-MAGNUM 42-50 TPR INSRTSTD LOT # 877460. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS LOCATION IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY LEGAL THAT THE PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY WAS REVISED TWELVE (12) YEARS LATER DUE TO PAIN, PSEUDOTUMOR, AND ELEVATED METAL IONS. THE SHELL AND STEM WERE LEFT INTACT, AND A DUAL MOBILITY WAS PLACED WITHOUT COMPLICATION. 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
    627475 M2A-MAGNUM MOD HD SZ 46MM PROSTHETIC, HIP KWA ZIMMER BIOMET, INC. N/A 848380

    Patients

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