BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW 6.5MM X 25MM

    MDR report key: 17583214 · Received August 21, 2023

    Report

    Report Number
    0001825034-2023-01959
    Event Type
    Injury
    Date Received
    August 21, 2023
    Report Date
    October 11, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527461
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICES IN D10 INVOLVE THOSE IMPLANTED DURING THE INITIAL PROCEDURE. THE SURGEON IS UNSURE AT THIS TIME AS TO WHICH SCREW ACTUALLY FRACTURED AND THEREFORE THE SCREW REMAINS UNKNOWN AT THIS TIME. D10: 110024468 G7 DUAL MOBILITY LINER 60MM J LOT#: 512100 110031020 ITEM NAME: VIVACIT-E DM BEARING 28X60MM, LOT#: 64709980. 010000998 ITEM NAME: G7 SCREW 6.5MM X 25MM, LOT#: 7453205. 010000998 ITEM NAME: G7 SCREW 6.5MM X 25MM, LOT#: 6973105. 010000998 ITEM NAME: G7 SCREW 6.5MM X 25MM, LOT#: 3920103. 010000996 ITEM NAME: G7 SCREW 6.5MM X 15MM, LOT#: 7053137. 010000996 ITEM NAME: G7 SCREW 6.5MM X 15MM, LOT#: 6825841. 010000997 ITEM NAME: G7 SCREW 6.5MM X 20MM, LOT#: 7091303. 010000999 ITEM NAME: G7 SCREW 6.5MM X 30MM, LOT#: 7438777. 010000998 ITEM NAME: G7 SCREW 6.5MM X 25MM, LOT#: 7042299. 110010275 ITEM NAME: G7 OSSEOTI MULTIHOLE 74MM J, LOT#: R3674706A. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01958. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT CURRENTLY REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED:

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4 D4: (B)(4), EXPIRATION: FEB 25, 2031. (B)(4), EXPIRATION: DEC 06, 2026. (B)(4), EXPIRATION: JUN 16, 2031. (B)(4), EXPIRATION: JUL 15, 2030. (B)(4), EXPIRATION: AUG 19, 2031. (B)(4), EXPIRATION: JAN 30, 2033. (B)(4), EXPIRATION: JUN 10, 2031. H4: FEB 28, 2021; JUN 30, 2016; JUN 16, 2021; JUNE 31, 2020; AUG 19, 2021; JAN 30, 2023; JUN 10, 2021. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; 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 FOR THE SCREWS. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED THAT THE PATIENT WILL UNDERGO A REVISION IN THE FUTURE DUE TO SCREW FRACTURE AND CUP LOOSENING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785787 G7 SCREW 6.5MM X 25MM PROSTHETIC, HIP PBI ZIMMER BIOMET, INC. N/A 7453205 00880304527461
    958771 G7 SCREW 6.5MM X 25MM PROSTHETIC, HIP PBI ZIMMER BIOMET, INC. N/A 7453205 00880304527461

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| O