BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW 6.5MM X 60MM

    MDR report key: 20847626 · Received December 4, 2024

    Report

    Report Number
    0001825034-2024-02858
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 12, 2024
    Report Date
    February 26, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527522
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) G2: AUSTRALIA. D10: CAT #: 11-107122 / FREEDOM ALL POLY CUP 50MM / LOT #: 191490; CAT #: 00700006620 / 66MM CUP SIZE REVISION SHELL / LOT #: 65566013; 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED BEARING AND HEAD REMAINS ASSEMBLED, AND COVERED IN BIO DEBRIS. NO FURTHER OBSERVATIONS COULD BE NOTED USING THE IMAGE PROVIDED. NO PRODUCT WAS RETURNED; FURTHER VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEW OF THE AVAILABLE RECORDS 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. THE VISUALIZED ACETABULAR FIXATION SCREWS ARE INTACT. THE INCOMPLETELY VISUALIZED PROXIMAL FEMUR AND FEMORAL IMPLANT APPEAR NORMAL AND WITHOUT FRACTURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE X-RAY 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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." AS PER FREEDOM® CONSTRAINED SYSTEM IFU, "DO NOT MODIFY IMPLANTS. BEFORE USING A PRODUCT PLACED ON THE MARKET BY BIOMET, THE OPERATING SURGEON SHOULD STUDY CAREFULLY THE FOLLOWING RECOMMENDATIONS, WARNINGS AND INSTRUCTIONS, AS WELL AS THE AVAILABLE PRODUCT-SPECIFIC INFORMATION (E.G., PRODUCT LITERATURE, SURGICAL TECHNIQUE). ZIMMER OR BIOMET IS NOT LIABLE FOR COMPLICATIONS THAT MAY ARISE FROM THE USE OF THE DEVICE IN CIRCUMSTANCES OUTSIDE OF ZIMMER OR BIOMET¿S CONTROL INCLUDING, BUT NOT LIMITED TO, PRODUCT SELECTION AND DEVIATIONS FROM THE DEVICE¿S INDICATED USES OR SURGICAL TECHNIQUE." IT IS UNKNOWN IF THIS OFF LABEL USE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941820 G7 SCREW 6.5MM X 60MM PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. NI 3895696 00880304527522

    Patients

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