BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 56MM F

    MDR report key: 6806702 · Received August 21, 2017

    Report

    Report Number
    0001825034-2017-06125
    Event Type
    Injury
    Date Received
    August 21, 2017
    Date of Event
    October 25, 2017
    Report Date
    February 7, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 RELEVANT TO THE REPORTED EVENT 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

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS- PART: 110024464 NAME: G7 DUAL MOBILITY LINER 44 MM F LOT: 924650, PART: EP-200150 NAME: ACT ARTIC E1 HIP BRG 28 X 44 MM LOT: 802000, PART: 010000996 NAME: G7 SCREW 6.5 MM X 15 MM LOT: 3741173, PART: 010000996 NAME: G7 SCREW 6.5 MM X 15 MM LOT: 3805567, PART: 010000997 NAME: G7 SCREW 6.5 MM X 20 MM LOT: 3666651, PART: 010000997 NAME: G7 SCREW 6.5 MM X 20 MM LOT: 3974192, PART: 010001000 NAME: G7 SCREW 6.5 MM X 35 MM LOT: 3970984. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THAT A PATIENT WAS REVISED DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS BEING REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587517 G7 OSSEOTI MULTIHOLE 56MM F PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3969105

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R