BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 DUAL MOBILITY LINER 36MM B

    MDR report key: 9707526 · Received February 13, 2020

    Report

    Report Number
    0001825034-2020-00621
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Report Date
    May 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI# (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED DUE TO LIMITED INFORMATION RECEIVED. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: BIOMET LINER ,CAT#: 110024460, LOT#: 233130; UNKNOWN CUP, UNKNOWN STEM, UNKNOWN HEAD, UNKNOWN DUAL MOBILITY BEARING. FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO LOCATION OF DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. 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 - 2020 - 00622.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PRIMARY SURGERY. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE DUE TO DISLODGED G7 DUAL MOBILITY METAL LINER. 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
    170017 G7 DUAL MOBILITY LINER 36MM B PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 233130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R