BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 15229523 · Received August 15, 2022

    Report

    Report Number
    0001825034-2022-01851
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    February 3, 2020
    Report Date
    September 14, 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
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: US157852 LOT NUMBER: 932370 BRAND NAME: M2A-MAGNUM PF CUP. CATALOG NUMBER:139252 LOT NUMBER:764820 BRAND NAME: M2A-MAGNUM 42-50MM. CATALOG NUMBER:11-103204 LOT NUMBER:604530 BRAND NAME: TAPERLOC POR FMRL. CATALOG NUMBER: 157446 LOT NUMBER: 535600 BRAND NAME: M2A-MAGNUM MOD HD . MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT. 0001825034-2022-01849. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: COMPONENT CODE: MECHANICAL (G04) - HEAD. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: COMPLICATION OF INTERNAL LEFT HIP PROSTHESIS ¿ HIP PAIN ASSOCIATED WITH RECALLED TOTAL HIP ARTHROPLASTY HARDWARE. ELEVATED METAL IONS LEVELS; BASED ON HER SYMPTOMS AND SERUM IRON LEVELS, ELECTED FOR REVISION. PRIOR TO REACHING THE FASCIA OF THE GLUTEUS MAXIMUS, FOUND PSEUDOTUMOR- DEBRIDED. METAL STAINED TISSUE WAS DEBRIDED. TROCHANTERIC BURSA HAD SIGNIFICANT INFLAMMATORY TISSUE WITH MINIMAL METAL STAINED TISSUE. DEBRIDED SCAR TISSUE, SUBSTANTIAL AMOUNT OF SCAR TISSUE UNDERNEATH THE GLUTEUS MEDIUS ANTERIORLY- DEBRIDED. PROCEDURE FINDINGS: METALLOSIS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 0

    T WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND ELEVATED METAL IONS APPROXIMATELY 12 YEARS POST IMPLANTATION. DURING THE REVISION, METAL-STAINED TISSUE WAS DEBRIDED, PSEUDOTUMOR WAS REMOVED, AND MULTIPLE AREAS OF SCAR TISSUE WERE DEBRIDED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166408 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 535600

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R SEE H10 NARRATIVE.