BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 NEUTRAL E1 LINER 32MM G

    MDR report key: 19523706 · Received June 12, 2024

    Report

    Report Number
    0001825034-2024-01570
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    June 3, 2024
    Report Date
    October 7, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526372
    PMA / PMN Number
    K121874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT WAS RETURNED AND EVALUATED. A VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED NO VISIBLE DAMAGE TO THE SCALLOPS, OUTER DIAMETER, LOCKING FEATURE, OR INNER RADIUS OF THE DEVICE. A DIMENSIONAL ANALYSIS DETERMINED THAT MEASUREMENTS MET PRODUCT SPECIFICATIONS WHERE MEASURED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT CANNOT BE CONFIRMED. 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# 110010268 LOT# 7213914 G7 OSSEOTI MULTIHOLE 60MM G. G2: FOREIGN: COUNTRY: SINGAPORE. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP ARTHROSCOPY, THE LINER WAS UNABLE TO LOCK INTO THE SHELL DESPITE USING THE RECOMMENDED SURGICAL TECHNIQUE. THERE WAS A 30-MINUTE DELAY WHILE TRYING ALL WAYS TO ENGAGE THE LINER INTO THE SHELL. AN ELEVATED 32MM LINER WAS USED INSTEAD. THERE WAS NO PATIENT IMPACT, NO MEDICAL INTERVENTIONS, AND NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136519 G7 NEUTRAL E1 LINER 32MM G PROTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 7500780 00880304526372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown