BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 FINNED 3 HOLE SHELL

    MDR report key: 8867533 · Received August 6, 2019

    Report

    Report Number
    0001825034-2019-03455
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 1, 2019
    Report Date
    November 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K142746
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    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). CONCOMITANT MEDICAL PRODUCTS: ITEM # 010000818, G7 HI-WALL ARCOMXL LNR, LOT # 6126575. ITEM # 51-104110, TAPERLOC STEM, LOT # 6341460. ITEM #12-115121, CER BIOLOXD MOD HD, LOT # 2971338. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03450.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRIMARY LEFT TOTAL HIP ARTHROPLASTY (THA) SURGERY WAS PERFORMED. UPON ATTEMPTING TO SEAT THE LINER IT FAILED TO SEAT. AN ADDITIONAL ATTEMPT WAS MADE WITH THE SAME LINER, BUT IT AGAIN FAILED TO SEAT. A NEW LINER WAS REQUESTED AND IT WAS NOTED PLASTIC WAS NOTICED TO HAVE FLAKED OFF (PEELED AWAY) AT SOME SPOTS ON THE FIRST LINER. NOTHING FELL INTO THE SURGICAL WOUND. NO HARM OR INJURY TO PATIENT WAS NOTED. A NEW LINER WAS USED TO COMPLETE THE PROCEDURE AND WORKED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659797 G7 FINNED 3 HOLE SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 6395058

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR