BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 60 MM LENGTH 6.5 MM DIA.

    MDR report key: 21584223 · Received March 12, 2025

    Report

    Report Number
    0002648920-2025-00068
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    November 12, 2024
    Report Date
    March 10, 2025
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    UDI-DI
    00889024127708
    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

    (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. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED AN EXPLANTED BEARING WITH HEAD ASSEMBLED WITHIN, COVERED IN BIODEBRIS. FURTHER OBSERVATIONS CANNOT BE MADE BASED ON THE IMAGE ALONE DUE TO REDUCED IMAGE QUALITY. NO PRODUCT WAS RETURNED; FURTHER VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL AND IDENTIFIED THE FOLLOWING: THE RIGHT HIP ARTHROPLASTY COMPONENTS ARE ANATOMICALLY ALIGNED. THERE IS A SUSPECTED CORTICAL DEFECT OF THE MEDIAL ACETABULAR WALL CORRELATING WITH THE FRACTURE DESCRIBED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, IT IS KNOWN THAT A FREEDOM ALL POLY CUP WAS USED WITH THE TMARS REVISION SHELL, AND THIS IS CONSIDERED OFF LABEL USE PER IFU. IT STATES UNDER COMPATIBILITY "DO NOT USE COMPONENTS OF THE TRABECULAR METAL ACETABULAR REVISION SYSTEM (TMARS) WITH COMPONENTS OF ANY OTHER SYSTEM OR MANUFACTURER UNLESS AUTHORIZED BY ZIMMER BIOMET." BASED ON THE MEDICAL IMAGE REVIEW, THE COMPLAINT IS CONFIRMED. 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

    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
    1615780 BONE SCREW SELF-TAPPING 60 MM LENGTH 6.5 MM DIA. PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. 64776802 00889024127708

    Patients

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