BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 28MM A

    MDR report key: 9146823 · Received October 2, 2019

    Report

    Report Number
    0001825034-2019-04418
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 25, 2019
    Report Date
    January 29, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI#: (B)(4). THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D4, D10, G4, G7, H2, H3, H6, H10. THE EVENT WAS CONFIRMED WITH PRODUCT RECEIVED. VISUAL INSPECTION FOUND SMALL SCRATCHES AND SCUFFS IN 1 LOCATION ON THE OUTER RADIUS. THE REMAINDER OF THE OUTER RADIUS AND BARB ARE FREE FROM DAMAGE. AN INDENTATION RUNS ALONG THE ELEVATED SCALLOPS AT A UNIFORM HEIGHT. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG# 010000757 G7 10 DEG ARCOMXL LINER 28MM A LOT# 3882068, CATALOG# 010000659 G7 PPS LTD ACET SHELL 44A LOT# 6129679, CATALOG# 010000874 G7 10 DEG E1 LINER 28MM A LOT# 6569774, CATALOG# 110003625 BIOLOX DELTA CER LNR 28MM B LOT# 6022564, CATALOG# 650-0830 DELTA CER FM HD 028/-3.5 12/14 LOT# 2019020164, CATALOG# 010000660 G7 PPS LTD ACET SHELL 46B LOT# 6360904, CATALOG# 650-0951 MICRO TPRLC STD PC 6MM (12/14) LOT# 6594650. FOREIGN: (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04417, 0001825034-2019-04418, 0001825034-2019-04420.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER WOULD NOT LOCK IN THE ACETABULAR SHELL. SURGEON USED ANOTHER, LARGER SHELL AND LINER TO COMPLETE THE SURGERY. 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
    940269 G7 HI-WALL E1 LINER 28MM A PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6167725

    Patients

    Seq Age Sex Outcome Treatment
    1