BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAGNER SL REVISION® HIP STEM

    MDR report key: 21700939 · Received March 26, 2025

    Report

    Report Number
    0009613350-2025-00194
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    November 18, 2019
    Report Date
    June 4, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430709
    PMA / PMN Number
    K200112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H10, H11. CORRECTED: A4. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBIDITIES, AND PERIOPERATIVE MANAGEMENT. DEEP VEIN THROMBOSIS (BLOOD CLOT), OR DVT, OCCURS WHEN A BLOOD CLOT FORMS IN ONE OF THE DEEP VEINS OF THE BODY. THIS CAN HAPPEN IF A VEIN BECOMES DAMAGED OR IF THE BLOOD FLOW WITHIN A VEIN SLOWS DOWN OR STOPS. TOTAL JOINT PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVELY TO PREVENT DVT FORMATION. EVEN WITH THE ADMINISTRATION OF PREVENTIVE MEDICATION, DVTS CAN STILL DEVELOP. AS THE COMPLAINT INDICATED, A POST-OPERATIVE COMPLICATION OCCURRED, AND MEDICAL INTERVENTION WAS REQUIRED FOR TREATMENT. 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

    (B)(4): D10: ITEM # 00877501436, BIOLOX® DELTA CERAMIC TAPER LINER, LOT # 2863896; ITEM # 00877503601, BIOLOX DELTA HD 12/14 36X-3.5, LOT # 2990978; ITEM # 00875506002, ALLOFIT®-S IT ALLOCLASSIC®, SHELL FOR ACETABULUM, LOT # 2975526; ITEM # 00223200118, CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. CABLE 22 IN. (559 MM) LENGTH, LOT # 64347715; ITEM # UNKNOWN, UNKNOWN SCREW 30MM, LOT # UNKNOWN; ITEM # UNKNOWN, UNKNOWN SCREW 35MM, LOT # UNKNOWN; ITEM # UNKNOWN, UNKNOWN SCREW 40MM, LOT # UNKNOWN. G2: REPORT SOURCE CANADA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD A LEFT TOTAL HIP REVISION. SUBSEQUENTLY, THE PATIENT DEVELOPED A POSTOPERATIVE DEEP VEIN THROMBOSIS DESPITE ASPIRIN PROPHYLAXIS. 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
    716283 WAGNER SL REVISION® HIP STEM PROSTHESIS, HIP LZO ZIMMER GMBH 2860125 00889024430709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other