BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD 12/14 TAPER 36 MM DIAMETER +3.5 MM NECK LENGTH

    MDR report key: 20039084 · Received August 22, 2024

    Report

    Report Number
    0001822565-2024-02726
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    August 15, 2024
    Report Date
    October 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024498891
    PMA / PMN Number
    K183457
    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. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED} UPDATED: G3; H2; H3; H4; H6. PROPOSED CODE: MECHANICAL (G04) HEAD. NO PRODUCT WAS RETURNED ONE IMAGE WAS PROVIDED WHICH SHOWS THE HEAD AND LINER REMOVED AND ON THE TABLE WITH THE PATIENT BIO ON IT. NO OTHER INFORMATION COULD BE OBTAINED FROM THE IMAGE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IMPLANT FIT IS MAINTAINED. THERE IS MALALIGNMENT SECONDARY TO THE ARTHROPLASTY DISLOCATION. BONE QUALITY IS OSTEOPENIC. 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). D10: CAT# 00811400218 LOT# 65521424 FEMORAL STEM 12/14 NECK TAPER STD. OFFSET SIZE 2 180 MM STEM LENGTH. CAT# 010000703 LOT# 7453541 G7 BONEMASTER LTD ACET SHL 52E. CAT# 010000896 LOT# 6848098 G7 10 DEG E1 LINER 36MM E. G2: FOREIGN: AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR LATER DUE TO DISLOCATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28981 FEMORAL HEAD 12/14 TAPER 36 MM DIAMETER +3.5 MM NECK LENGTH PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 3010487 00889024498891

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.