BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEU +5MM E1 LINER 40MM I

    MDR report key: 11453438 · Received March 10, 2021

    Report

    Report Number
    0001825034-2021-00658
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    December 16, 2020
    Report Date
    May 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K142882
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 110010271 ¿ G7 MULTIHOLE SHELL - R3713970A; 11-300817 ¿ ARCOS DISTAL STEM ¿ 838140; 11-301323 ¿ ARCOS CONE - 213330; 650-1067 ¿ BIOLOX DELTA TAPER 2971099; 650-1058 ¿ BIOLOX DELTA HEAD ¿ 2958882; 00625006520 - BONE SCREW - 63187339; 00625006540 ¿ BONE SCREW ¿ 63604707; 00625006540 ¿ BONE SCREW ¿ 64202377; 00625006515 ¿ BONE SCREW - 629035991. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNING FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. 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. THE FOLLOWING SECTIONS WERE UPDATED/ CORRECTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. 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 PATIENT UNDERWENT A FIRST STAGE REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION, A SECOND STAGE REVISION APPROXIMATELY 2 MONTHS LATER AND 2 MORE SURGERIES WITHIN 9 MONTHS. SUBSEQUENTLY, THE PATIENT UNDERWENT ANOTHER REVISION APPROXIMATELY 7 MONTHS LATER DUE TO UNKNOWN REASONS. THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350626 G7 NEU +5MM E1 LINER 40MM I PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6326653

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R