BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X40MM

    MDR report key: 8915830 · Received August 21, 2019

    Report

    Report Number
    0001825034-2019-03587
    Event Type
    Injury
    Date Received
    August 21, 2019
    Report Date
    December 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: EP-200146, LOT #: 593720, HIP BEARING; ITEM #: 110024462, LOT#: 921750, LINER; ITEM #: 010000661, G7 ACETABULAR SHELL, LOT #: 6289138; ITEM #: 51-107110, TAPERLOC COMPLETE MICRO FEMORAL STEM LOT #: 6278522. 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 THAT WOULD CONTRIBUTE TO THIS 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 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). CONCOMITANT MEDICAL PRODUCTS: ITEM #010000847 G7 ACETABULAR LINER LOT #6234106, ITEM # 010000661 G7 ACETABULAR SHELL LOT # 6289138, ITEM #51-107110 TAPERLOC COMPLETE MICRO FEMORAL STEM LOT #6278522. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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 -2019 -03584.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS EXPERIENCING LIMITED RANGE OF MOTION AFTER UNDERGOING LEFT HIP REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709862 ACT ARTIC E1 HIP BRG 28X40MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. 593720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other