BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 BM SO 14.0

    MDR report key: 18003537 · Received October 25, 2023

    Report

    Report Number
    0001825034-2023-02465
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    October 4, 2023
    Report Date
    December 8, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K120030
    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. COMPONENT CODE: MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. COMPLAINT CONFIRMED BASED ON EVALUATION OF THE PROVIDED X-RAYS. REVIEW OF THE DEVICE HISTORY RECORD(S) 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: THE FEMORAL IMPLANT IS LOOSE AND SUBSIDED SECONDARY TO THE PERIPROSTHETIC FRACTURE. THE ACETABULAR IMPLANT FIT IS NORMAL. ALIGNMENT WAS INITIALLY NORMAL BUT FOLLOWING FRACTURE THERE IS HIP VARUS. NO CONTRIBUTING FACTORS ARE IDENTIFIED. 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# 163667 LOT# J7347499 32MM MOD HEAD COCR -6MM NECK. CAT# 31-323230 LOT# 65892208 3.2MMX30MM RNGLC+ ACET DRL BIT. CAT# 010000925 LOT# 6731060 G7 HI-WALL E1 LINER 32MM C. CAT# 110010242 LOT# 7213841 G7 OSSEOTI 3 HOLE SHELL 48MM C. CAT# 010000998 LOT# 7394616 G7 SCREW 6.5MM X 25MM. G2: FOREIGN: AUSTRALIA THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS WAS NOT APPROVED FOR RETURNED BY 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 THE PATIENT UNDERWENT A HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 MONTH LATER DUE TO SUBSIDENCE AND FEMORAL FRACTURE. THE FEMORAL STEM WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151631 TPRLC 133 MP TYPE1 BM SO 14.0 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 7292605

    Patients

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