BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 17135873 · Received June 15, 2023

    Report

    Report Number
    0001825034-2023-01341
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    September 15, 2022
    Report Date
    September 28, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. ONLY THE M2A-MAGNUM MOD HD SZ 48MM ITEM# 157448 LOT# 937450 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THERE ARE BLACK MARKS AND INDENTATIONS TO THE FACE OF THE DEVICE. THE OUTSIDE DIAMETER SHOW SCUFFING. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVEN WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. PATIENT NOTED PAIN ON UNSPECIFIED DATE, WORKUP CONSISTED OF METAL ION ANALYSIS AND MIR WITH ABNORMAL RESULTS. THE COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS AND RETURNED PRODUCT. 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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 001825034-2023-01348. D10: CAT #: US157854 / M2A-MAGNUM PF CUP 54ODX48ID /LOT #: 875280. CAT #: 103206 / TAPERLOC POR FMRL 12.5X145 / LOT #: 930840. CAT #: 139254 / M2A-MAGNUM 42-50MM TPR INSRT-3 / LOT #: 937870. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY TWELVE YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED ION LEVELS AND METAL RELATED PATHOLOGY. THE HEAD COMPONENT WAS REMOVED AND REPLACED WITH NO COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838212 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 937450

    Patients

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