BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PLASMA

    MDR report key: 10712420 · Received October 21, 2020

    Report

    Report Number
    0001822565-2020-03596
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 24, 2020
    Report Date
    November 19, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K192660
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE PRESENCE OF WHITE DEBRIS ON THE IMPLANT, PARTICULARLY IN A RECESSED HOLE AT THE PROXIMAL END. THE SMALL WHITE PARTICLES ARE VISUALLY CONSISTENT WITH THE WHITE FOAM INSERT (ITEM #88-8800-042-00) USED TO RETAIN THE IMPLANT WITHIN THE STERILE CAVITIES. NOT ALL PACKAGING MATERIALS WERE RETURNED. COMPLAINT IS CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORD(S) FOR ITEM #00771101620, LOT #62153730 IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE LIKELY CONDITION OF THE PART WHEN IT LEFT ZIMMER BIOMET CONTROL IS CONSIDERED CONFORMING BASED ON THE EVALUATION OF THE RETURNED PRODUCT, THE DHR REVIEW, AND THE POTENTIAL TRANSIT AGE OF THE DEVICE (8 YEARS). THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO TRANSIT DAMAGE. THE DEVICE EVALUATION FOUND NO MALFUNCTION AND THE EVENT DID NOT CONTRIBUTE TO INJURY, THEREFORE THIS WOULD NOT BE CONSIDERED A REPORTABLE EVENT. 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 ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 AN ML TAPER IMPLANT WAS OPENED- THE IMPLANT WAS COVERED IN SMALL PLASTIC LOOKING PARTICLES. THE DECISION WAS MADE TO NOT IMPLANT THE DEVICE AND REMOVE IT FROM THE STERILE FIELD. NO IMPACT TO THE PATIENT OR PROCEDURE- A DUPLICATE IMPLANT WAS OPENED AND IMPLANTED INTO THE PATIENT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177037 FEMORAL STEM 12/14 NECK TAPER PLASMA PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 62153730

    Patients

    Seq Age Sex Outcome Treatment
    1