BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO B-MTRC MP FP HO 10

    MDR report key: 12915230 · Received December 2, 2021

    Report

    Report Number
    0001825034-2021-03212
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 8, 2021
    Report Date
    January 7, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304697928
    PMA / PMN Number
    K143009
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL DEVICES: 110017105-G7 FINNED 4 HOLE SHELL 56F-7013000; 20104006-LINER NEUTRAL 40 MM I.D. SIZE F FOR USE WITH G7 ACETABULAR SYSTEM ONLY-65060764; 650-1058-CER BIOLOXD OPTION HD 40MM 0-3062903; 650-1065-CER OPTION TYPE 1 TPR SLEVE -3 PE 1-3048759. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THERE IS NO VISIBLE DAMAGE TO THE DEVICE. ADDITIONALLY, DIMENSIONAL ANALYSIS WAS PERFORMED. ANALYSIS IDENTIFIED THE LENGTH OF THE DEVICE WAS CHECKED AND FOUND WITHIN CONFORMANCE TO THE PRINT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    IT WAS REPORTED WHILE CANAL BROACHING, SURGEON SEQUENTIALLY BROACHED FROM 7MM UP TO 10MM WITH ZB ECHO MICRO BROACHES, AS WELL AS TRIALING. HE FELT THE 10MM BROACH WAS THE CORRECT SIZE, FIT AND FILL. HE ASKED FOR THE 10MM ECHO MICRO IMPLANT. THE 10MM IMPLANT SUBSIDED. SURGERY WAS COMPLETED WITH A 11MM ECHO MICRO IMPLANT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813441 ECHO B-MTRC MP FP HO 10 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 272170 00880304697928

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown