BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 58G

    MDR report key: 11274521 · Received February 3, 2021

    Report

    Report Number
    0001825034-2021-00335
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    August 21, 2020
    Report Date
    June 7, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: CATALOG#: 192114 ECHO POR FMRL LAT NC 14X150MM LOT#: 133930. CATALOG#: 650-1162 DELTA CER FEM HD 32/0MM T1 LOT#: 2016120241. CATALOG#: 110003629 BIOLOX DELTA CER LNR 32MM G LOT#: 3409704. THE EVENT WAS CONFIRMED WITH MEDICAL RECORDS AND RADIOGRAPHS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). D.O.B: UNKNOWN MONTH AND DAY IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 192114, ECHO POR FMRL LAT NC 14X150MM, LOT#: 133930. FOREIGN REPORT SOURCE: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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: 0001825034-2021-00334.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2 YEARS POST IMPLANTATION, THE PATIENT WAS EXPERIENCING AN INCREASE IN PAIN WITH MOVEMENT AND FREQUENT NOISE. PATIENT STATES NOISE IS GETTING WORSE, AND WAS PRESCRIBED PHYSICAL THERAPY. 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
    168414 G7 PPS LTD ACET SHELL 58G PROSTHESIS, HIPS PBI ZIMMER BIOMET, INC. N/A 3726509

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R