BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 32MM D

    MDR report key: 12108717 · Received July 2, 2021

    Report

    Report Number
    0001825034-2021-01942
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 10, 2021
    Report Date
    November 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00990304527027
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE G7 HI-WALL E1 LINER 32MM D ITEM# 010000926 LOT# 6951140 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE LINER HAS DAMAGE TO THE OD AND THE LOCKING FEATURE OF THE DEVICE. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PART # 110010243/ G7 OSSEOTI 3 HOLE SHELL / LOT # 6964389. PART # 00489405010/ ACETABULAR REVISION SYSTEM / LOT # 64634258. PART # 103534/ LOW PROFILE SCREW/ LOT # 2017110367. PART # 103531/ LOW PROFILE SCREW/ LOT # 2019031668. PART # 103535 // LOW PROFILE SCREW/ LOT # 2879045. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER COULDN'T BE LOCKED INTO THE SHELL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVEN IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007426 G7 HI-WALL E1 LINER 32MM D PROSTHESIS HIP PBI ZIMMER BIOMET, INC. NI 6951140 00990304527027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10