BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T M/H RAD 2HL SHL 41/54MM

    MDR report key: 7292652 · Received February 23, 2018

    Report

    Report Number
    0001825034-2018-00759
    Event Type
    Injury
    Date Received
    February 23, 2018
    Report Date
    February 8, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED: THE COMPLAINT IS CONFIRMED BASED ON THE RETURNED DEVICES THAT WERE PROVIDED. VISUAL INSPECTION SHOWS MINOR SCUFFING AND SIGNS OF USE. REVIEW OF DEVICE HISTORY RECORDS AND FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ABNORMALITIES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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 ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE FOLLOW UP MDR IS SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 11-163690, 32 MM M2A HI CARBON HD +6 MM NK, 484560, THE 15-105044, M2A TPR HI CARBON 41/32 MM LNR, 716000. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2018-00760, 0001825034-2018-00761.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135873 M2A-T M/H RAD 2HL SHL 41/54MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 336100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R