BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW

    MDR report key: 6607596 · Received June 2, 2017

    Report

    Report Number
    0001825034-2017-03545
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    May 2, 2017
    Report Date
    November 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RETAINED BY THE PATIENT AND WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION; HOWEVER, AN INVESTIGATION HAS BEEN INITIATED. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED. THE SCREW INVOLVED IN THIS EVENT CANNOT BE DETERMINED. IT COULD BE: CATALOG # - 010000998, LOT # - 3624605, EXPIRATION - NI, PMA # - K121874, MANUFACTURE DATE - NI. OR IT COULD BE: CATALOG # - 010000999, LOT # - 3604098, EXPIRATION - NI, PMA # - K121874, MANUFACTURE DATE - NI. CONCOMITANT MEDICAL PRODUCTS- G7 ACETABULAR SHELL P/N 010000662 L/N 3626596; G7 SCREW P/N 010000998 L/N 3624605; G7 SCREW P/N 010000999 L/N 3604098; FEMORAL STEM P/N 00771100600 L/N 61963053; BIOLOX FEMORAL HEAD P/N 00877403201 L/N 2811973. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03505, 0001825034-2017-03506.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING WAS UPDATED FOR CATALOG # 010000999, LOT # 3604098. (B)(4). MANUFACTURE DATE - AUG 25, 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE THREE MONTHS POST-IMPLANTATION DUE TO RANGE OF MOTION COMPLICATIONS, SQUEAKING DURING AMBULATION AND DISASSOCIATION OF THE LINER FROM THE ACETABULAR SHELL. THE LINER REPORTEDLY MIGRATED AROUND THE FEMORAL HEAD, RESULTING IN THE FEMORAL HEAD ARTICULATING WITH THE ACETABULAR METAL SHELL. THE SURGEON INDICATED THAT ONE OF THE ACETABULAR SCREWS MAY NOT HAVE BEEN FULLY INSERTED, WHICH WOULD INTERFERE WITH FULL SEATING OF THE LINER. DURING THE PROCEDURE, THE ACETABULAR SCREWS, LINER, APICAL HOLE PLUG AND CERAMIC HEAD WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388793 G7 SCREW PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R