BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW

    MDR report key: 7762572 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06668
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    July 22, 2014
    Report Date
    October 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: G7 SCREW, # ITEM 010000999, LOT 2955334; G7 ACETABULAR LINER, # ITEM 010000662, LOT 2901309; G7 SCREW, # ITEM 010000998, LOT 2955317; G7 NEUTRAL E1 LINER, # ITEM 010000848, LOT 2921354; BIOLOX DELTA OPTION CERAMIC HEAD 32MM, # ITEM 650-1056, LOT 302950; BIOLOX OPTION TAPER ADAPTER -3 NECK, # ITEM 650-1065, LOT 711130; TAPERLOC COMPLETE MICRO FEMORAL STEM, # ITEM 51-149050, LOT 2931661. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-06667, 0001825034-2018-06666 AND 0001825034-2018-06670. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE DUE TO LOOSENING, INSTABILITY AND IMPLANT FRACTURE. X-RAY REVIEW STATED THAT THERE IS PROGRESSIVE LOOSENING AND ROTATIONAL MALALIGNMENT OF THE ACETABULAR COMPONENT AND SOME OF THE SCREWS MAY BE FRACTURED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604910 G7 SCREW PROSTHESIS HIP PBI ZIMMER BIOMET, INC. 2955334

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R