BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM

    MDR report key: 18345462 · Received December 18, 2023

    Report

    Report Number
    0001822565-2023-03670
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    November 23, 2023
    Report Date
    February 15, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K183457
    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

    (B)(4). D1: CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM NECK LENGTH FOR USE WITH FREEDOM CONSTRAINED LINERS D10: 010000985 G7 FREEDOM CONST E1 LNR 36MM G 6771746 G2: FOREIGN: AUSTRALIA 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PROPOSED COMPONENT CODE: MECHANICAL (G04) HEAD. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE UNCHANGED. IT WAS NOTED IN FOLLOW UPS THAT THE PATIENT HAS A HISTORY OF NON-COMPLIANCE, HOWEVER IT IS UNKNOWN HOW THE PATIENT IS NON-COMPLIANT AND IF IT CAUSED OR CONTRIBUTED TO THE DISLOCATION. THIS COMPLAINT CANNOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919821 CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM PROTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 3041611

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Hospitalization| R SEE H10 NARRATIVE.