BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 32MM B

    MDR report key: 9272813 · Received November 4, 2019

    Report

    Report Number
    0001825034-2019-04916
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    September 2, 2019
    Report Date
    April 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CATALOG NUMBER:51-199334 LOT NUMBER: 202470 BRAND NAME: SIRIUS HIP STEM 34-C. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: (SUMMARIZED BY HCP). FINDINGS: 1 YEAR FOLLOW UP. O HHS 87.9, SLIGHT PAIN, FUNCTIONAL ACTIVITIES WITH EASE, NORMAL GAIT, LLD 0CM O EQ5D 0.827, MODERATE PAIN, NO PROBLEMS PERFORMING ACTIVITIES, HEALTH STATE 100 3 YEAR FOLLOW UP. O HHS 65, MODERATE PAIN WITH SOME LIMITATION OF ACTIVITY, SLIGHT LIMP, LLD 1CM, O EQ5D 0.378, MODERATE PAIN, SOME PROBLEMS WITH ACTIVITIES, HEALTH STATE 30. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:010000700 LOT NUMBER: 3395124 BRAND NAME:G7 BONEMASTER LTD, CATALOG NUMBER:010000846 LOT NUMBER: 3464197 BRAND NAME:G7 NEUTRAL E1 LINER, CATALOG NUMBER:51-199334 LOT NUMBER:UNKNOWN BRAND NAME:SIRIUS HIP STEM 34-C, CATALOG NUMBER:51-199300 LOT NUMBER: UNKNOWN BRAND NAME: SIRIUS WINGED CENTRALIZER, CATALOG NUMBER:650-1163 LOT NUMBER: 3377385 BRAND NAME:DELTA CER FEM HD 32/-3MM T1. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04915, 0001825034-2019-04917, 0001825034-2019-04918. 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. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED MODERATE PAIN, A NEW ONSET SLIGHT LIMP, SOME LIMITATIONS WITH ADLS (ACTIVITIES OF DAILY LIVING), AND DECREASE IN OVERALL SATISFACTION AND HEALTH STATE SCORES APPROXIMATELY 3 YEARS POST IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066972 G7 NEUTRAL E1 LINER 32MM B PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3464197

    Patients

    Seq Age Sex Outcome Treatment
    1 Other