BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 54MM F 4MM F

    MDR report key: 10626329 · Received October 5, 2020

    Report

    Report Number
    0001825034-2020-03688
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    June 26, 2020
    Report Date
    December 23, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING MILD ILIOPSOAS TENDINITIS, ILIOPSOAS INJECTION AND PHYSICAL THERAPY PRESCRIBED. 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.

    Additional Manufacturer Narrative · 0

    UPON ASSESSMENT OF MEDICAL RECORDS RECEIVED, THE SURGEON STATES HE DOES NOT THINK THE REPORTED COMPLICATIONS ORIGINATED FROM THE HIP IMPLANTS AS THE PATIENT HAD THIS BEFORE AND AFTER REPLACEMENT WHICH HAS BEEN UNRESPONSIVE TO TREATMENT. THEREFORE, THIS EVENT IS NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    UPON ASSESSMENT OF MEDICAL RECORDS RECEIVED, THE SURGEON STATES HE DOES NOT THINK THE REPORTED COMPLICATIONS ORIGINATED FROM THE HIP IMPLANTS AS THE PATIENT HAD THIS BEFORE AND AFTER REPLACEMENT WHICH HAS BEEN UNRESPONSIVE TO TREATMENT. THEREFORE, THIS EVENT IS NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 650-0660 ¿ DELTA CERAMIC HEAD ¿ 3030546; 193011 ¿ ECHO STEM ¿ 995030; 30103606 ¿ LINER ¿ 64319477. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03689.

    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
    1095838 G7 OSSEOTI 4 HOLE SHELL 54MM F 4MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6725596

    Patients

    Seq Age Sex Outcome Treatment
    1 Other