BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 10 DEG E1 LINER 36MM H

    MDR report key: 17730268 · Received September 12, 2023

    Report

    Report Number
    0001825034-2023-02139
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    August 17, 2023
    Report Date
    October 3, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526792
    PMA / PMN Number
    K121874
    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. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE BEARING IS COVERED IN BIO-DEBRIS NO DEFINITE DAMAGE CAN BE SEEN. POSSIBLE DAMAGE TO THE LOCKING FEATURE, IT IS UNKNOWN IF THE DAMAGE OCCURRED DURING REMOVAL. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. 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# 00877503604 LOT# 2993314 ITEM: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, 36/+7, TAPER 12/14. G2: FOREIGN ¿ AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. 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 THAT A PATIENT UNDERWENT A HIP PROCEDURE AND SUBSEQUENTLY UNDERWENT A REVISION THE NEXT DAY DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104565 G7 10 DEG E1 LINER 36MM H PROTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6406697 00880304526792

    Patients

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