BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 FINNED 4 HOLE SHELL 54F

    MDR report key: 7064053 · Received November 28, 2017

    Report

    Report Number
    0001825034-2017-10588
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    March 21, 2017
    Report Date
    February 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK142746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 10588, 0001825034-2017-04576, 0001825034 - 2017 - 10589, 0001825034 - 2017 - 10590, 0001825034 - 2017 - 10591. CONCOMITANT PRODUCTS: 110017104 G7 FINNED 4 HOLE SHELL 54F LOT 3703149. 51-100140 TPRLC 133 FP TYPE1 PPS SO 14.0 LOT 3722132. 010000858 G7 NEUTRAL E1 LINER 36MM F LOT 3794200. 650-1065 CER OPTION TYPE 1 TPR SLEVE -3 LOT 843120. 650-1057 CER BIOLOXD OPTION HD 36MM LOT 100590. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS LIMPING AND HAS TROUBLE WEIGHT BEARING STATUS POST RIGHT TOTAL HIP ARTHROPLASTY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842525 G7 FINNED 4 HOLE SHELL 54F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 3703149

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other