BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 17622937 · Received August 25, 2023

    Report

    Report Number
    0001825034-2023-02009
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    December 9, 2022
    Report Date
    December 8, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. 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/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: ¿ FAILED RIGHT THA SECONDARY TO MOM ARTICULATION WITH METALLOSIS, LACKS PERIARTICULAR HIP TISSUES SECONDARY TO METALLOSIS ¿ GENERAL, EBL 600ML, SAME POSTEROLATERAL APPROACH USED ¿ PRESENTED WITH INCREASING PAIN, COBALT AND CHROMIUM LEVELS ELEVATED, SLIGHT FLUID NOTED ON MRI BUT NO GROSS ALTR ¿ UPON ENTRY, DARK METAL STAINING OF THE TISSUES CONSISTENT WITH METALLOSIS ENCOUNTERED ¿ NO SIGNIFICANT DAMAGE TO THE TRUNNION NOTED UPON REMOVAL OF THE FEMORAL HEAD ¿ SLIGHT DEFICIENCIES NOTED IN THE ACETABULAR WALL ¿ SHELL FOUND ¿QUITE ANTEVERTED AND QUITE VERTICAL¿, REMOVED WITHOUT SIGNIFICANT BONE LOSS (INITIAL OP NOTE STATES THAT CUP WAS PLACED IN A ¿SAFE, STABLE POSITION¿; THEREFORE, MALPOSITION IS NOT CALLED OUT) ¿ SIGNIFICANT LAXITIES IN THE SOFT TISSUES NOTED ¿ CAPSULE CLOSED WITH ADEQUATE TENSION AND STABLE ROM ¿ STEM REMAINED INTACT, REMAINING COMPONENTS REVISED WITHOUT COMPLICATION. THE COMPLAINT IS CONFIRMED VIA THE PROVIDED MEDICAL RECORDS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02010, 0001825034-2023-02011. D10: CAT #: 157446 / M2A-MAGNUM MOD HD SZ 46MM 46MM/ LOT #: 022580. CAT #: 139254 / M2A-MAGNUM 42-50MM TPR INSRT-3 0/-3MMT1 / LOT #: 382900. 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 FIFTEEN YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED METAL ION LEVELS, METALLOSIS AND SECONDARY SOFT TISSUE DAMAGE. DURING THE REVISION, DARK METAL STAINING AND JOINT LAXITY WAS NOTED. THE STEM REMAINED INTACT AND THE CUP, HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283438 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 379370

    Patients

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