BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTR HD 36MM T1 STD

    MDR report key: 12932976 · Received December 6, 2021

    Report

    Report Number
    0001825034-2021-03257
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    October 5, 2021
    Report Date
    January 31, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 150457 LOT# 685010 OSS FINN MOD PROX FMRL RT 7CM; CAT# 150361LOT# 120380 OSS CEMENTED IM STEM 12MMX90MM; CAT# 150466LOT# 328190 OSS 7CM DIAHPYSEAL SEGMENT; CAT# 11-107126 LOT# 653510R FREEDOM ALL POLY CUP 58MM. FOREIGN: COUNTRY: (B)(6) CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2021 - 03256.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 4 DAYS POST IMPLANTATION DUE TO DISLOCATION AND INFECTION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830799 FREEDOM CONSTR HD 36MM T1 STD PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 313820

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H SEE H10 NARRATIVE