BEUDAMED
    FDA Adverse Event Injury Summary report: N

    66MM CUP SIZE REVISION SHELL

    MDR report key: 20846742 · Received December 4, 2024

    Report

    Report Number
    0001822565-2024-03821
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 12, 2024
    Report Date
    March 10, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K001759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 #: 00662406530 / BONE SCREW SELF-TAPPING 30 MM LENGTH 6.5 MM DIA. / LOT #: 65140220; 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.

    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 3005751028 PARSIPPANY.

    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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977568 66MM CUP SIZE REVISION SHELL PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. NI 65566013

    Patients

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