BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 36MM E

    MDR report key: 18452294 · Received January 5, 2024

    Report

    Report Number
    0001825034-2024-00035
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    November 23, 2019
    Report Date
    March 22, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526426
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 650-1057 LOT# 537390 CER BIOLOXD OPTION HD 36MM; CAT# 110017103 LOT# 3841407 G7 FINNED 3 HOLE SHELL 52E; CAT# 650-1065 LOT# 329700 CER OPTION TYPE 1 TPR SLEVE -3; CAT# 51-103090 LOT# 3880920 TPRLC 133 TYPE1 PPS SO 9X137MM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: X-RAY: IN GOOD POSITION, NO RADIOLUCENT LINES, NO OSTEOLYSIS, GOOD BONY INGROWTH. PATIENT WAS BENDING OVER AND FELT HER HIP POP. SUCCESSFUL REDUCTION OF DISLOCATION UNDER MODERATE SEDATION. X-RAY: DISLOCATED RIGHT THA, NO EVIDENCE OF FRACTURE, LEFT HIP IS ALIGNED. 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 A PATIENT HAD AN INITIAL RIGHT HIP TOTAL ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DISLOCATION APPROXIMATELY 3 YEARS LATER DUE TO A FALL. THE HIP WAS SUCCESSFULLY REDUCED WITH MODERATE SEDATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    587271 G7 NEUTRAL E1 LINER 36MM E PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3915013 00880304526426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H10 NARRATIVE.