BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 12407098 · Received September 1, 2021

    Report

    Report Number
    0001825034-2021-02496
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    December 30, 2020
    Report Date
    September 1, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER 166316 ITEM NAME PROGRESSIVE POR FMRL10X130 RT LOT # 902170. ITEM NUMBER 139256 ITEM NAME M2A-MAGNUM 42-50 TPR INSRTSTD LOT # 877460. 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 - 01169.

    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
    1309021 M2A-MAGNUM PF CUP 52ODX46ID PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 515350

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R