BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 36MM E

    MDR report key: 11415496 · Received March 4, 2021

    Report

    Report Number
    0001825034-2021-00622
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 25, 2021
    Report Date
    July 8, 2021
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: -CATALOG#: 010000663 G7 PPS LTD ACET SHELL 52E LOT#: 6736723 -CATALOG#: 01.06010.006 AVENIR MULLER STEM 6 STANDARD LOT#: 3039609 -CATALOG#: 00877503602 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14 LOT#: 3053095.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE RECEIVED, HOWEVER, THE EVENT COULD NOT BE CONFIRMED. FINDINGS: GENERAL, ASA 3. GAMMA IM NAIL REMOVED. THA PLACED WITH NO INTRAOP COMPLICATIONS DICTATED. DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE HAS BEEN DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SEVERAL ATTEMPTS, THE LINER WOULD NOT FIT INTO THE CUP. THE LINER WAS SCRAPPED. NO ADVERSE CONSEQUENCES WERE REPORTED. 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
    315338 G7 HI-WALL E1 LINER 36MM E PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6434277

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE| UNKNOWN SHELL