BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE PRIMARY FEMORAL 133 FP TYPE1 PPS HO 8.0

    MDR report key: 20053819 · Received August 23, 2024

    Report

    Report Number
    0001825034-2024-02064
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    August 8, 2024
    Report Date
    January 17, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304489721
    PMA / PMN Number
    K200196
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00620205222 LOT# 65712808 SHELL POROUS WITH CLUSTER HOLES 52 MM. CAT# 00625006530 LOT# J7405189 BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH. CAT# 00625006525 LOT# 65601589 BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH. CAT# 00630505036 LOT# 65672783 LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS. CAT# 650-0660 LOT# 3140405 DELTA CERAMIC FEM HD 36/-3MM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. 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 INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: D4; G3; H2; H3; H4; H6. PROPOSED COMPONENT CODE: MECHANICAL: STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. FINDINGS: SEVERE FEMORAL HEAD AND ACETABULAR ARTHRITIS. LEFT LENGTH GAIN WAS NOTED TO BE 10MM PER OUR PREOPERATIVE PLAN. EXCELLENT STABILITY WAS NOTED IN ABDUCTION, EXTERNAL ROTATION, EXTENSION AS WELL AS IN FLEXION, ADDUCTION, AND INTERNAL ROTATION. 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.

    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 LEG LENGTH DISCREPANCY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698047 TAPERLOC COMPLETE PRIMARY FEMORAL 133 FP TYPE1 PPS HO 8.0 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 7220633 00880304489721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R