BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 54MM F

    MDR report key: 6614912 · Received June 6, 2017

    Report

    Report Number
    0001825034-2017-03524
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    May 10, 2017
    Report Date
    October 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: P/N EP-200150 L/N 695420 ACT ARTIC E1 HIP BRG 28X44MM; P/N 163638 L/N 043780 28MM COCR MOD HD +6MM NO SKIRT; P/N 110024464 L/N 584270 G7 DUAL MOBILITY LINER 44MM F; UNKNOWN FEMORAL STEM. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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). CONCOMITANT MEDICAL PRODUCTS - G7 SCREW 6.5 MM X 20 MM/ PN 010000997/ LN 3843247, G7 SCREW 6.5 MM X 20 MM/ PN 010000997/ LN 3852838, G7 SCREW 6.5 MM X 20 MM/ PN 010000997/ LN 3443807, G7 SCREW 6.5 MM X 25 MM/ PN 010000998/ LN 3863008. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03525, 0001825034-2017-03526, 0001825034-2017-03527, 0001825034-2017-03528.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION SURGERY APPROXIMATELY SEVEN MONTHS POST IMPLANTATION DUE LOOSENING OF THE CUP AND SCREW FRACTURE. IT WAS REPORTED THE CUP DID NOT GROW IN TO THE ACETABULUM. THERE WERE NO COMPLICATIONS OR DELAYS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395700 G7 OSSEOTI MULTIHOLE 54MM F PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3500810

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R