BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3 0/-3MMT1

    MDR report key: 9667203 · Received February 4, 2020

    Report

    Report Number
    0001825034-2020-00497
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    February 20, 2017
    Report Date
    April 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 103204 - TAPERLOC STEM - 86481, 157450 - M2A HEAD - 601030, US157856 - M2A SHELL - 704150. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING PATIENT WAS EXPERIENCING SYMPTOMS OF PAIN, SWELLING, INFLAMMATION, METALLOSIS, ELEVATED METAL ION LEVELS, AND TISSUE DAMAGE. MRI FOUND PSEUDOTUMOR AND 15 ML OF CLOUDY YELLOW SYNOVIAL FLUID WAS REMOVED. CORROSION NOTED ON THE TRUNNION. AREAS OF LYSIS AROUND THE PROXIMAL FEMUR BUT ON GROWTH WAS PALPABLE AND IMPLANT WAS WELL FIXED. LYSIS WAS FOUND AROUND THE SHELL CIRCUMFERENTIALLY. NO SEGMENTAL BONE CONNECTED TO THE ACETABULAR COMPONENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO PAIN, DYSFUNCTION AND LOSS OF RANGE OF MOTION. DURING THE PROCEDURE, ADVERSE LOCAL TISSUE REACTION AND PSEUDOTUMOR WERE FOUND. CORROSION WAS ALSO NOTED ON THE TRUNNION OF THE STEM AND LYSIS WAS FOUND AROUND THE FEMUR AND CUP. THE HEAD, TAPER, AND CUP WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TAPERLOC POR FMRL 10X140, PN 103204, LN UNKNOWN, M2A-MAGNUM MOD HD SZ 50MM 50MM, PN 157450, LN UNKNOWN , M2A-MAGNUM PF CUP 56ODX50ID, PN US157856, LN UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00495, 0001825034-2020-00496, 0001825034-2020-00498. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY DUE TO UNKNOWN REASONS. APPROXIMATELY 10 YEAR LATER THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN, DYSFUNCTION, AND LOSS OF RANGE OF MOTION. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME FOR REVIEW. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128851 M2A-MAGNUM 42-50MM TPR INSRT-3 0/-3MMT1 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 330980

    Patients

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