BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 17885115 · Received October 6, 2023

    Report

    Report Number
    0001825034-2023-02281
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    October 27, 2022
    Report Date
    November 10, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02282. D10: CAT #: US157850 / M2A-MAGNUM PF CUP 50ODX44ID / LOT #: 739880. CAT #: 14-103203 / TAPERLOC MICROP FMRL 9.0MM / LOT #: 820230. CAT #: 139256 / M2A-MAGNUM 42-50 TPR INSRT STD / LOT #: 916640. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4; B5; G3; H2; H3; H6 PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: S PAIN, WEAKNESS, AND SOME MECHANICAL SYMPTOMS (UNKNOWN ADDITIONAL SYMPTOMS, INSUFFICIENT INFO ON THIS ALLEGATION PROVIDED) DEVELOPED. RADIOGRAPHS REVEALED SOME OSTEOLYSIS AROUND BOTH SIDES, BUT APPEARED TO BE WELL FIXED AND WELL ALIGNED ON THE STEM SIDE. COBALT CHROMIUM MARKERS WERE ELEVATED AND PSEUDOTUMOR. ALL THE TISSUE WAS STAINED GRAY AND NECROTIC, MASSIVE DEBRIDEMENT BACK TO BLEEDING TISSUE. THE FEMORAL HEAD ALONG WITH TITANIUM ADAPTOR WERE REMOVED, THERE WAS NO SIGNIFICANT CORROSION FOUND. THE ACETABULAR COMPONENT WAS WELL FIXED. THE COMPLAINT IS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. A DEFINITIVE ROOT CAUSE COULD NOT 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

    IT WAS REPORTED A PATIENT UNDERWENT A HIP PROCEDURE APPROXIMATELY THIRTEEN YEARS POST IMPLANTATION DUE TO ELEVATED METAL ION LEVELS, OSTEOLYSIS, PAIN, WEAKNESS AND METAL-RELATED PATHOLOGY INCLUDING A PSEUDOTUMOR. DURING THE PROCEDURE, NECROSIS WAS NOTED AS WELL LARGE AMOUNTS OF STAINED JOINT FLUID WAS DRAINED. THE HEAD AND TITANIUM ADAPTER WERE REMOVED AND REPLACED WITH NO FURTHER COMPLICATION REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307677 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 682200

    Patients

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