BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 LONGEVITY NEUTRAL 36MM F

    MDR report key: 13597821 · Received February 25, 2022

    Report

    Report Number
    0001822565-2022-00587
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    January 2, 2022
    Report Date
    February 22, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024518759
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: 110010245 ¿ G7 SHELL ¿ 65123551; 650-0662 ¿ DELTA CERAMIC HEAD ¿ 3062870; 193015 ¿ ECHO STEM ¿ 473220. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. IF A DVT/ BLOOD CLOT BREAKS FREE, IT MAY TRAVEL THROUGH THE BLOODSTREAM AND BLOCK BLOOD FLOW TO THE LUNGS. THIS COMPLICATION IS CALLED A PULMONARY EMBOLISM. TOTAL JOINT PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVE FOR A PERIOD OF TIME TO HELP PREVENT THE DEVELOPMENT OF DVT/BLOOD CLOT FORMATION THAT CAN LEAD TO AN PE. AS THE COMPLAINT INDICATED THE PATIENT DEVELOPED A POST-OPERATIVE COMPLICATION, IT CAN BE IMPLIED MEDICAL INTERVENTION WAS COMPLETED TO TREAT THE PE. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 00593.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: 110010245 ¿ G7 SHELL ¿ 65123551; 650-0662 ¿ DELTA CERAMIC HEAD ¿ 3062870; 193015 ¿ ECHO STEM ¿ 473220. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. IF A DVT/ BLOOD CLOT BREAKS FREE, IT MAY TRAVEL THROUGH THE BLOODSTREAM AND BLOCK BLOOD FLOW TO THE LUNGS. THIS COMPLICATION IS CALLED A PULMONARY EMBOLISM. TOTAL JOINT PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVE FOR A PERIOD OF TIME TO HELP PREVENT THE DEVELOPMENT OF DVT/BLOOD CLOT FORMATION THAT CAN LEAD TO AN PE. AS THE COMPLAINT INDICATED THE PATIENT DEVELOPED A POST-OPERATIVE COMPLICATION, IT CAN BE IMPLIED MEDICAL INTERVENTION WAS COMPLETED TO TREAT THE PE. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 00593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT DEVELOPED A PULMONARY EMBOLISM APPROXIMATELY 2 YEARS POST LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT WAS HOSPITALIZED OVERNIGHT, TREATED MEDICALLY AND COMPLICATIONS RESOLVED. COMPONENTS REMAINED IMPLANTED ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT DEVELOPED A PULMONARY EMBOLISM APPROXIMATELY 2 YEARS POST LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT WAS HOSPITALIZED OVERNIGHT, TREATED MEDICALLY AND COMPLICATIONS RESOLVED. COMPONENTS REMAINED IMPLANTED 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
    1230543 G7 LONGEVITY NEUTRAL 36MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65056535 00889024518759

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| O