BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC LAT 16X160

    MDR report key: 8828621 · Received July 25, 2019

    Report

    Report Number
    0001825034-2019-03227
    Event Type
    Injury
    Date Received
    July 25, 2019
    Report Date
    June 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. H3 OTHER TEXT : PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: US157856 LOT NUMBER:921710 BRAND NAME:M2A MAGNUM CUP, CATALOG NUMBER:157450 LOT NUMBER:959590 BRAND NAME: M2A MAGNUM HEAD, CATALOG NUMBER:X11-180316 LOT NUMBER:425400 BRAND NAME: BIOMETRIC STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00105, 0001825034-2019-00107 . REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO FAILED LEFT HIP CAUSED BY ADVERSE LOCAL REACTION TO METAL ON METAL WITH MULTIPLE SYMPTOMS. DURING THE PROCEDURE, PSEUDOTUMOR WAS IDENTIFIED AND EXCISED. PRE-OPERATIVE BLOOD WORK SHOWED THAT PATIENT HAD ELEVATED METAL IONS - CR AT 12.7 AND CO AT 16.3. MRI SHOWED METAL DEBRIS AND ADVERSE REACTION. ADVERSE TISSUE REACTION WAS FOUND THROUGHOUT THE JOINT WITH NEUROLYSIS OF LEFT SCIATIC NERVE. THERE WAS BONE LOSS ON THE SUPERIOR POSTERIOR ASPECT OF THE ACETABULUM. OSTEOLYSIS WAS NOTED AT THE ANTERIOR INFERIOR PORTION OF THE ACETABULUM, POSTERIOR PORTION OF THE STEM, AND AT GREATER TROCHANTER. THE CUP AND HEAD WERE REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN, BONE DESTRUCTION, METALLOSIS AND METAL WEAR APPROXIMATELY 8 YEARS POST IMPLANTATION. 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
    622228 BI-METRIC/X POR NC LAT 16X160 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 425400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R