BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9920829 · Received April 3, 2020

    Report

    Report Number
    0001825034-2020-01424
    Event Type
    Injury
    Date Received
    April 3, 2020
    Date of Event
    February 18, 2020
    Report Date
    June 23, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE: UNKNOWN DATE IN 2010. CONCOMITANT MEDICAL PRODUCTS: BIOMET M2A HEAD LOT#157446 CAT#880790. UNKNOWN STEM. UNKNOWN CUP. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01423.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT INITIAL THA. SUBSEQUENTLY, THE PATIENT COMPLAINED OF HIP PAIN APPROXIMATELY 8 YEARS LATER. PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 2 YEARS LATER; THE HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. IT WAS NOTED THAT NO FINDINGS OF METALLOSIS OR PSEUDOTUMOR COULD BE CONFIRMED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384402 M2A-MAGNUM 42-50MM TPR INSRT-3 0/-3MMT1 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 827880

    Patients

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