BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 32MM F

    MDR report key: 14113201 · Received April 14, 2022

    Report

    Report Number
    0001825034-2022-00910
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    October 9, 2019
    Report Date
    June 6, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526365
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). YEAR OF BIRTH (B)(6). CONCOMITANT MEDICAL DEVICES: REF 192115 LOT 883990 BIMETRIC STEM; REF 163670 LOT J6083692 HEAD; REF 010000665 LOT 3886967 G7 ACETABULAR CUP. FOREIGN: COUNTRY: (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 00909.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D4, G3, H2, H3, H4, H6 REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: DISLOCATION AND SUBLUXATION WITH A CLOSED REDUCTION. ADDITIONAL DISLOCATIONS OCCURRED PROMPTING A REVISION, THE CUP AND LINER WERE EXCHANGED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY ONE AND A HALF YEARS POST IMPLANTATION DUE TO DISLOCATIONS. THE LINER AND HEAD WERE EXCHANGED. THE STEM AND CUP REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133632 G7 NEUTRAL E1 LINER 32MM F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6207265 00880304526365

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R