BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRDM CNSTR HD 36MM T12/14 -6MM

    MDR report key: 10885805 · Received November 23, 2020

    Report

    Report Number
    0001825034-2020-03995
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    July 25, 2017
    Report Date
    December 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K043537
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G4; H2; H3; H6 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, IT WAS IDENTIFIED THAT OFF LABEL USE COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SUMMARY OF THE INVESTIGATION FINDINGS HAVE BEEN SENT TO THE CUSTOMER. 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: 00771301500 ¿ M/L TAPER STEM ¿ 60757504. 00784800300 ¿ M/L TAPER NECK ¿ 60786701. 11-107324 ¿ FREEDOM LINER ¿ 943470. 106058 ¿ RINGLOC SHELL ¿ 926570. 103533 ¿ LOW PROFILE SCREW ¿ 134310. 103534 ¿ LOW PROFILE SCREW ¿ 768790. HEAD INITIALLY REPORTED UNDER 0002648920 - 2020 - 00278. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. 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
    1350767 FRDM CNSTR HD 36MM T12/14 -6MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 963950

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R