BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 FREEDOM CONST E1 LNR 36MM D

    MDR report key: 11787662 · Received May 6, 2021

    Report

    Report Number
    0001825034-2021-01309
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 9, 2021
    Report Date
    September 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4, D9, G3; H2; H3; H4; H6. ONE G7 FREEDOM CONST E1 LNR 36MM D ITEM# 010000982 LOT# 6760372 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE LOCKING RING HAD SOME SCUFFING BUT NO FURTHER DAMAGE. THE LINER HAD DAMAGE TO THE LOCKING FEATURE, INDENTATIONS ON THE LIP AND ON THE OUTSIDE RADIUS OF THE DEVICE. THERE WAS ALSO A CUTOUT UNDER THE SCALLOPS. THE DIMENSIONAL ANALYSIS OF THE LINER WAS CONFORMING TO SPECIFICATIONS DURING MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT 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). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP SURGERY SURGEON IMPLANTED LINER INTO CUP, USED REGULAR FORCE WITH HAMMER. SURGEON EXPLAINED THAT THE METAL RING ON LINER SLIPPED OFF IN ANTERIOR AND THAN COMPLETELY OFF. SURGEON STATED HE HAD PREVIOUSLY CLEANED AROUND CUP, TO MAKE SURE, THERE WAS NOT OSTEOPHYTES AND WAS ALSO CAREFUL TO INSERT THE LINERS GROVES INTO THE RIGHT EMPLACEMENTS INTO CUP. SURGEON WAS AWARE OF REGULAR FINAL PLACEMENT OF CONSTRAINED LINERS. THERE WAS NO OTHER LINERS ON SITE. PATIENT HAD TO STAY UNDER ANESTHESIA FOR 1HR 15MIN UNTIL ANOTHER LINER WAS RETRIEVED FROM ANOTHER HOSPITAL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683886 G7 FREEDOM CONST E1 LNR 36MM D PROSTHESIS HIP PBI ZIMMER BIOMET, INC. NI 6760372

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR