BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X25 SELF-TAP

    MDR report key: 18485243 · Received January 10, 2024

    Report

    Report Number
    0001822565-2024-00124
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    April 18, 2017
    Report Date
    January 18, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024119819
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}: UPDATED: D4; G3; H2; H3; H4; H6. 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. 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: CAT# 650-1057 LOT# 2857354 CER BIOLOXD OPTION HD 36MM CAT# 650-1064 LOT# 2887392 CER OPTION TYPE 1 TPR SLEVE -6 CAT# 110017102 LOT# 3805701 G7 FINNED 3 HOLE SHELL 50D CAT# 010000856 LOT# 3964987 G7 NEUTRAL E1 LINER 36MM D CAT# 51-100090 LOT# 3943768 TPRLC 133 FP TYPE1 PPS SO 9.0. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT 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 · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED AN ACUTE PULMONARY EMBOLISM 4 DAYS LATER. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND TREATED WITH MEDICATION. PATIENT WAS SENT HOME IN STABLE CONDITION WITH HOME HEALTH CARE AND IS INSTRUCTED TO STAY ON MEDICATION FOR 3 MONTHS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251670 BONE SCR 6.5X25 SELF-TAP PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63585018 00889024119819

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE