BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX54MM

    MDR report key: 9155950 · Received October 4, 2019

    Report

    Report Number
    0001825034-2019-04458
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    August 28, 2017
    Report Date
    October 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. 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 REPORT 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). 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. CONCOMITANT MEDICAL PRODUCTS: PART: 11-173662, M2A 38MM MOD HD STD NK, LOT: 958630, PART: 15-105054, M2A 1 PC SHELL 38MMX54MM, LOT: 827800, PART: UNK, 13XL 47 MM LATERALIZED TAPERLOCK FEMORAL POROUS COATED STEM, LOT: 726140. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2014-05466.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT THA AND SUBSEQUENTLY WAS REVISED TWELVE AND A HALF YEARS LATER DUE TO PAIN, SWELLING, INFLAMMATION, METALLOSIS, DAMAGE TO SURROUNDING BONE AND TISSUE AND LACK OF MOBILITY. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952710 M2A 1 PC SHELL 38MMX54MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 827800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R