BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR SYSTEM

    MDR report key: 6844493 · Received September 6, 2017

    Report

    Report Number
    0001825034-2017-06913
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    October 25, 2017
    Report Date
    February 9, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: BIOLOX® OPTION, HEAD, XL,28/+7, TAPER 12/14 P/N 00877702804 L/N 2844958. TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT P/N 00489405420 L/N 63271869. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED 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

    CONCOMITANT PRODUCTS: PART: 110024464 NAME: G7 DUAL MOBILITY LINER 44MM F LOT: 924650, PART: EP-200150 NAME: ACT ARTIC E1 HIP BRG 28X44MM LOT: 802000, PART: 010000996 NAME: G7 SCREW 6.5MM X 15MM LOT: 3741173, PART: 010000996 NAME: G7 SCREW 6.5MM X 15MM LOT: 3805567, PART: 010000997 NAME: G7 SCREW 6.5MM X 20MM LOT: 3666651, PART: 010000997 NAME: G7 SCREW 6.5MM X 20MM LOT: 3974192, PART: 010001000 NAME: G7 SCREW 6.5MM X 35MM LOT: 3970984. THE DEVICE WAS NOT RETURNED FOR MANUFACTURER EVALUATION. ALTHOUGH A REVISION SURGERY HAS BEEN INDICATED, IT HAS NOT BEEN CONFIRMED THE PATIENT HAS BEEN REVISED AND THE DEVICES ARE ASSUMED YET IMPLANTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS COMPLAINT. PLEASE SEE ADDITIONAL REPORTS: 0001825034-2017-06908, 0001825034-2017-06909, 0001825034-2017-06910, 0001825034-2017-06911, 0001825034-2017-06912, 0001825034-2017-06913, 0001825034-2017-06914, 0001825034-2017-06125-1. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 THE PATIENT IS BEING CONSIDERED FOR REVISION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627239 G7 ACETABULAR SYSTEM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3974192

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R