BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER NEUTRAL 36 MM I.D. SIZE F

    MDR report key: 10626328 · Received October 5, 2020

    Report

    Report Number
    0001822565-2020-03422
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    June 26, 2020
    Report Date
    December 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF MEDICAL RECORDS IT WAS FOUND THAT THE PATIENT WAS HAVING THE SAME COMPLICATIONS BEFORE THE DEVICES WERE IMPLANTED. THE SURGEON CONFIRMED THAT THE DEVICES DID NOT CAUSE THE COMPLICATIONS THAT HAVE BEEN REPORTED AND THEREFORE, THIS DEVICE IS CONSIDERED TO BE NOT REPORTABLE.

    Description of Event or Problem · 0

    UPON REVIEW OF MEDICAL RECORDS IT WAS FOUND THAT THE PATIENT WAS HAVING THE SAME COMPLICATIONS BEFORE THE DEVICES WERE IMPLANTED. THE SURGEON CONFIRMED THAT THE DEVICES DID NOT CAUSE THE COMPLICATIONS THAT HAVE BEEN REPORTED AND THEREFORE, THIS DEVICE IS CONSIDERED TO BE NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 650-0660 ¿ DELTA CERAMIC HEAD ¿ 3030546; 110010245 ¿ G7 OSSEOTI SHELL ¿ 6725596; 193011 ¿ ECHO STEM ¿ 995030. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO PHYSICIAN APPROXIMATELY 1 MONTH POST RIGHT TOTAL HIP ARTHROPLASTY DUE TO ILIOPSOAS TENDONITIS AND TREATED WITH INJECTION AND PHYSICAL THERAPY. ALL DEVICES REMAIN IMPLANTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095837 LINER NEUTRAL 36 MM I.D. SIZE F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64319477

    Patients

    Seq Age Sex Outcome Treatment
    1 Other