BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 30 MM LENGTH 6.5 MM DIA.

    MDR report key: 20854231 · Received December 5, 2024

    Report

    Report Number
    0001822565-2024-03830
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    November 12, 2024
    Report Date
    March 10, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K840643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). G2: AUSTRALIA D10: CAT #: 11-107122 / FREEDOM ALL POLY CUP 50MM / LOT #: 191490 CAT #: 010001004 / G7 SCREW 6.5MM X 60MM / LOT #: 3895696 CAT #: 00700006620 / 66MM CUP SIZE REVISION SHELL / LOT #: 65566013 CAT #: 00662406560 / BONE SCREW SELF-TAPPING 60 MM LENGTH 6.5 MM DIA. / LOT #: 64776802 CAT #: 802403603 / CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM NECK LENGTH FOR USE WITH FREEDOM CONSTRAINED LINERS / LOT #: 3089039 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL HIP REVISION APPROXIMATELY ONE YEAR AND THREE MONTHS POST IMPLANTATION DUE TO AN ACETABULAR FRACTURE. THE SHELLS, SCREWS AND HEADS WERE REMOVED AND REPLACED. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489532 BONE SCREW SELF-TAPPING 30 MM LENGTH 6.5 MM DIA. PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. NI 65140220

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE.