BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY SHELL POROUS WITH CLUSTER HOLES 52 MM O.D.

    MDR report key: 18878857 · Received March 11, 2024

    Report

    Report Number
    0002648920-2024-00058
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    January 14, 2011
    Report Date
    March 12, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. DESPITE PROPHYLAXIS, DVTS CAN STILL DEVELOP WHICH CAN THEN BREAK FREE WITHIN THE VESSEL AND OCCLUDE OR BLOCK THE BLOOD FLOW IN THE LUNGS, KNOWN AS A PULMONARY EMBOLISM (PE). AS THE COMPLAINT INDICATED, A POST-OPERATIVE COMPLICATION OCCURRED, AND MEDICAL INTERVENTION WAS REQUIRED FOR TREATMENT. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED. 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). G2: FOREIGN: CANADA . D10: CAT# 6320-50-28 LOT# 61312811 LINER 20 DEGREE ELEVATED RIM 28 MM . CAT# 7711-11 LOT# 61487763 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT . CAT# 8018-28-02 LOT# 61558147 FEMORAL HEAD 12/14 TAPER. 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: 0001822565-2024-00843, 0001822565-2024-00844, 0002648920-2024-00059.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE DAY POST IMPLANTATION OF AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT DEVELOPED SIGNIFICANT SHORTNESS OF BREATH AND CHEST PAIN THAT WAS WORSE WITH DEEP BREATHING. THE PATIENT WAS DIAGNOSED WITH BILATERAL PULMONARY EMBOLISMS, WAS PLACED ON OXYGEN, AND GIVEN ANTICOAGULATION MEDICATION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968174 TRILOGY SHELL POROUS WITH CLUSTER HOLES 52 MM O.D. PROTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 61237861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R