BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 3 HOLE SHELL 52MM E 2MM E

    MDR report key: 7335118 · Received March 13, 2018

    Report

    Report Number
    0001825034-2018-01744
    Event Type
    Injury
    Date Received
    March 13, 2018
    Report Date
    April 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: EP-200148, ACT ARTIC E1 HIP BRG 28X42MM S48 DIA28, 511810; 110024463, G7 DUAL MOBILITY LINER 42MM E, 592880; 0106010003, AVENIR® MüLLER STEM, 2863214. 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 - 2018 - 01745 ; 0001825034 - 2018 - 01746; 0009613350-2018-00349 ; 0009613350-2018-00350. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. X-RAY REVIEW STATED THAT THE COMPONENTS OVERALL FIT AND ALIGNMENT IS APPROPRIATE. NORMAL BONE QUALITY. NO X-RAY EVIDENCE OF IMPLANT COMPONENT MALFUNCTION. NO SIGNS OF LOOSENING OR RADIOLUCENCY. MEDICAL RECORDS RECEIVED HAVE FOLLOW-UP NOTES FROM A DIFFERENT SURGEON CONFIRMING LEG LENGTH DISCREPANCY. HOWEVER, THE NOTES FROM THE INITIAL SURGEON DO NOT CONFIRM THE EVENT. LEG LENGTH WAS NOTED TO BE SATISFACTORY BY PRIMARY SURGEON. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS 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 THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY IS EXPERIENCING PAIN AND LEG LENGTH DISCREPANCY. THE PATIENT REPORTED THEIR LEFT LEG IS TWO CENTIMETERS LONGER THAN THE RIGHT LEG. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177175 G7 OSSEOTI 3 HOLE SHELL 52MM E 2MM E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 3906238

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O