BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW 6.5MM X 35MM

    MDR report key: 11929889 · Received June 3, 2021

    Report

    Report Number
    0001825034-2021-01694
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 12, 2021
    Report Date
    January 5, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; H2; H3; H4; H6 REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS RECEIVED. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE SCREW IS DEFORMED IN THE THREADED AREA. NO OTHER OBSERVATIONS CAN BE MADE FROM THE IMAGE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE SCREW TO BE BENT. MULTIPLE THREADS HAVE BEEN DAMAGED AND/OR DEFORMED. SCRATCHING WAS OBSERVED AROUND THE HEAD. NO DAMAGE TO THE TIP WAS OBSERVED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 163667 753080 32MM MOD HEAD COCR -6MM NECK; 110010245 6933261 G7 OSSEOTI 4 HOLE SHELL 54MM F; 192113 477040 ECHO POR FMRL LAT NC 13X145MM; 31-323230 013530 3.2MMX30MM RNGLC+ ACET DRL BIT; 010001000 6817845 G7 SCREW 6.5MM X 35MM; 010000928 6918278 G7 HI-WALL E1 LINER 32MM F. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE SCREW OF A G7 CUP WAS NOT SEATED CORRECTLY CAUSING THE SCREW TO BEND. THE SCREW WAS THEN REMOVED, ANOTHER HOLE WAS DRILLED, AND A NEW SCREW WAS PLACED INTO CUP. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826885 G7 SCREW 6.5MM X 35MM PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6288392

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention