BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FMRL RED NC 10X130MM

    MDR report key: 7980572 · Received October 18, 2018

    Report

    Report Number
    0001825034-2018-09825
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    September 20, 2018
    Report Date
    March 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. EVALUATION OF THE RETURNED DEVICE FOUND THE STEM TO BE IN GOOD OVERALL CONDITION. MINOR SURFACE SCRATCHES WERE OBSERVED ON THE TAPER. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE OVERALL LENGTH AND CROSS-SECTIONAL LENGTH AND WIDTH AT REFERENCE PLANE B. ALL CRITERIA WERE FOUND TO CONFORM TO PRINT SPECIFICATIONS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). EXACT WEIGHT IS UNKNOWN, SURGEON NOTES PATIENT IS OBESE. (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 192411 ¿ ECHO POR FEMORAL STEM ¿ 843620. (B)(4). 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 - 09827.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, PATIENT WAS IMPLANTED WITH STEM WHICH SANK LOWER THAN THE BROACH. THE STEM WAS THEN REMOVED AND PATIENT WAS BROACHED AND IMPLANTED FOR A BIGGER SIZE STEM. SAME ISSUE WITH STEM SINKING FURTHER THAN THE BROACHED OCCURRED A SECOND TIME. FINALLY SURGEON WAS ABLE TO GET THE THIRD SIZE STEM TO FIT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817958 ECHO POR FMRL RED NC 10X130MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 763630

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R