BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL HEAD

    MDR report key: 6411557 · Received March 16, 2017

    Report

    Report Number
    0001825034-2017-01692
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    February 4, 2017
    Report Date
    May 3, 2022
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM#010000669, G7 SHELL, LOT#3350575; ITEM #010000999, G7 SCREW, LOT #3365486, ITEM #010000999, G7 SHELL, LOT#3369626; ITEM #103207, TAPERLOC FEMORAL STEM, LOT#220990. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT 0001825034-2017-01685.

    Description of Event or Problem · 1

    IT WAS REPORTED IN MEDICAL NOTES RECEIVED THAT PATIENT EXPERIENCED DISLOCATION APPROXIMATELY 5 MONTHS POST-IMPLANTATION. IT IS UNKNOWN IF MEDICAL INTERVENTION TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193757 UNKNOWN FEMORAL HEAD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other SEE H10