BEUDAMED
    FDA Adverse Event Death Summary report: N

    G7 SCREW 6.5MM X 25MM

    MDR report key: 12287646 · Received August 6, 2021

    Report

    Report Number
    0001825034-2021-02287
    Event Type
    Death
    Date Received
    August 6, 2021
    Date of Event
    July 8, 2021
    Report Date
    January 6, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL RECORDS WERE NOT PROVIDED, HOWEVER, IT WAS NOTED BY THE SURGEON THE CASE WAS CHALLENGING BECAUSE OF THE SMALL PATIENT. IN A STANDARD TOTAL HIP REPLACEMENT, THE FINAL ACETABULAR CUP IS FIXATED INTO PLACE, THEN THE FEMUR IS TRIALED AND IMPLANTED, THEN THE FEMORAL HEAD IS PLACED. THE STANDARD TECHNIQUE IS TO PLACE A FINGER POSTERIORLY INTO THE SCIATIC NOTCH TO ASSESS BONE QUALITY FROM REAMING, SCREW PLACEMENT, AND TO ENSURE NO DAMAGE TO THE ILIUM. IT WAS REPORTED THAT THE SCREW SIZE USED WAS 25MM IN LENGTH. A REVIEW OF THE PRODUCT PORTFOLIO NOTED SMALLER SCREW SIZES, 15MM (010000996) AND 20MM (010000997), WHERE AVAILABLE. A FURTHER REVIEW OF THE REPORTED EVENT WAS COMPLETED BY ZIMMER BIOMET HEALTH CARE PROFESSIONALS (HCP) AND IT WAS NOTED THIS IS NORMAL SURGICAL PRACTICE THAT PROTECTING THE VESSELS AND BONE INTEGRITY ARE PRIMARY CONCERNS DURING ACETABULAR REAMING AND CUP IMPLANTATION. THE MAJOR BLOOD VESSELS TO CONSIDER ARE THE EXTERNAL ILIAC ARTERY AND VEIN, THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES, AND THE OBTURATOR ARTERY. BONE QUALITY AND THICKNESS FURTHER CONTRIBUTE TO CONSIDERATION FOR SCREW LENGTH AND PLACEMENT AS THIN OR SOFT BONE, SMALL FRAME, AND ANY DYSPLASIA INCREASE THE RISK OF PROTRUSION. OF THE FOUR QUADRANTS IN THE ACETABULUM THE SAFE ZONE OR TARGET ZONE POSING THE LEAST AMOUNT OF RISK WOULD BE THE POSTERIOR-SUPERIOR QUADRANT, THE OTHER QUADRANTS WOULD POSE AN INCREASED RISK TO THE PATIENT. AS THE VASCULAR SURGEON NOTED A SCREW IN THE GREATER VESSEL, IT IS ASSUMED THE SCREW PENETRATED THE ILIUM. A REVIEW OF THE DEVICE LABELING, IFU (INSTRUCTION FOR USE), INDICATES THE ACETABULAR SHELL CAN BE USED WITH OPTIONAL G7 SCREWS THAT VARY IN LENGTH FROM 15MM TO 70MM. UNDER THE WARNING SECTION, IT IS NOTED THE SURGEON IS TO BE THOROUGHLY FAMILIAR WITH THE IMPLANTS AND SURGICAL TECHNIQUES PRIOR TO PERFORMING SURGERY. THE OPERATING SURGEON SHOULD STUDY CAREFULLY THE FOLLOWING RECOMMENDATIONS, WARNINGS, AND INSTRUCTIONS AS WELL AS THE AVAILABLE PRODUCT-SPECIFIC INFORMATION (IFU, SURGICAL TECHNIQUE). WARNING INDICATES PERFORATION ENTIRELY THROUGH THE PELVIC BONE WITH SCREWS THAT ARE TOO LONG CAN CAUSE DAMAGE TO BODY STRUCTURE (BLOOD VESSELS, ETC) LOCATED ON THE INTERIOR SIDE OF THE PELVIS. A REVIEW OF THE PROVIDED SURGICAL TECHNIQUE INDICATES IN CASES WHERE PRESS-FIT STABILITY IS IN QUESTION, OR WHERE THE BONE QUALITY IS NOT OPTIMAL, SUPPLEMENTARY SCREW FIXATION IS ADVISED. SCREW PLACEMENT MUST BE CHOSEN CAREFULLY TO AVOID INJURY TO NEUROVASCULAR STRUCTURES. THE OPTIMAL POSITION FOR SCREW PLACEMENT IS TYPICALLY IN THE POSTERIOR/SUPERIOR QUADRANT OF THE ACETABULUM. NOTE: PLACEMENT OF SCREWS OUTSIDE OF THE SAFE ZONE MAY INADVERTENTLY INJURE NEUROVASCULAR STRUCTURES AND SHOULD BE UTILIZED AT THE DISCRETION OF THE OPERATING SURGEON. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR AS THE PELVIC BONE WAS PERFORATED BY A G7 FIXATION SCREW. AS NOTED IN THE IFU UNDER WARNING SECTION IT STATES PERFORATION ENTIRELY THROUGH THE PELVIC BONE WITH DOME FIXATION SCREWS IS TO BE COMPLETELY AVOIDED. CAUTION IS TO BE USED WHEN DETERMINING AND SELECTING THE LENGTH OF SCREWS TO BE USED, AS PERFORATION THROUGH THE PELVIC BONE WITH SCREWS THAT ARE TOO LONG CAN CAUSE DAMAGE TO BODY STRUCTURES (BLOOD VESSELS, ETC.) LOCATED ON THE INTERIOR SIDE OF THE PELVIS. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM# 010000998/ G7 SCREW 6.5MM / LOT # 6730916. ITEM # 110010263 / G7 OSSEOTI MULTIHOLE /LOT # 6815826. ITEM # 163668 / 32MM MOD HEAD /LOT # 753925. ITEM # 51-102070/ TPRLC XR FP TYPE1 PPS/LOT # 6121890. ITEM # 010000926/ G7 HI-WALL E1 LINER/LOT # 6854128. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021-02307.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL 3D PLANNED WITH THE FORMUS SOFTWARE AND EXECUTED WITH INTELLIJOINT NAVIGATION. IT WAS NOTED THE CASE PROCEEDED AS EXPECTED HOWEVER; IT WAS A CHALLENGING CASE AS THE PATIENT WAS SMALL AND DIFFICULT TO BALANCE LENGTH/OFFSET. WHEN IMPACTING THE ACETABULAR COMPONENT, THE SURGEON WAS NOT SATISFIED WITH THE FIXATION AND DECIDED TO SUPPLEMENT THE FIXATION WITH TWO SCREWS. THE NAVIGATION WAS ABANDONED AFTER THE CUP WAS IMPLANTED DUE TO THE FEMORAL ARRAY FIXATION SCREW BEING LOOSE; AS REPORTED THIS DID NOT IMPACT THE COMPLETION OF THE CASE OR CONTRIBUTE TO THE ADVERSE EVENT. THE DEFINITIVE FEMORAL COMPONENTS WERE IMPLANTED, GLUTEAL TENDON REPAIR (WITH ANCHORS FROM ANOTHER SUPPLIER) AND INCISION CLOSED. UPON COMPLETION OF THE CASE, IT WAS NOTED THE ANESTHESIA TEAM WAS CONCERNED WITH THE PATIENTS HEMODYNAMIC STATUS. IT WAS LATER REPORTED THE PATIENT REQUIRED CPR AND A VASCULAR SURGEON CALLED INTO THE THEATER IN WHICH A LAPAROTOMY WAS PERFORMED AND IDENTIFIED A SCREW IN ONE OF THE GREAT VESSELS. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED DUE TO BLOOD LOSS/HYPOVOLAEMIA. 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
    1186421 G7 SCREW 6.5MM X 25MM HIP PROSTESIS LPH ZIMMER BIOMET, INC. NI 6637708

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| D SEE H10.