BEUDAMED
    FDA Adverse Event Death Summary report: N

    CM LAG SCREW RET SHAFT ASIA-

    MDR report key: 21835046 · Received April 14, 2025

    Report

    Report Number
    0009613350-2025-00292
    Event Type
    Death
    Date Received
    April 14, 2025
    Date of Event
    March 18, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K231114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): D10: ITEM # 47249318110, CMN FEMORAL NAIL, CCD 125°, LEFT, ø 10 MM, 18 CM, LOT # 3123884. ITEM # 47248509510, ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 95 MM, INCLUDING SET SCREW, LOT # 3182509. ITEM # 00249000450, CM LAG SCREW INSERTER- ASIA, LOT # UNKOWN. ITEM # 47248403050, 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD, LOT # 66260877. ITEM # 47248700200, CEPHALOMEDULLARY NAIL CAP 0 MM HEIGHT, LOT # 66435604. G2: REPORT SOURCE JAPAN 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.

    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, H3, H6, H11. NO PRODUCTS WERE RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INTRAMEDULLARY NAIL AND SCREW FIXATION OF THE PROXIMAL LEFT FEMUR IS ANATOMICALLY ALIGNED. NO RESIDUAL FRACTURE LUCENCY IS IDENTIFIED. THERE IS NO EVIDENCE OF IMPLANT LOOSENING. NO IMPLANT OR ANATOMICAL CONCERNS ARE IDENTIFIED. A REVIEW OF THE INSTRUCTIONS FOR USE "ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAIL - TIVANIUM TI-6AL-4V ALLOY" MENTIONS UNDER "IMPORTANT INFORMATION TO THE OPERATING SURGEON" THAT "THE MANUFACTURER, THE IMPORTER AND THE SUPPLIERS OF ZIMMER PRODUCTS ARE NOT LIABLE FOR COMPLICATIONS OR OTHER EFFECTS THAT MAY OCCUR FOR REASONS SUCH AS INCORRECT INDICATIONS OR SURGICAL TECHNIQUE, THE USE OF THE DEVICE OUTSIDE OF ITS INDICATED USES, UNSUITABLE CHOICE OF MATERIAL OR HANDLING THEREOF, UNSUITABLE USE OR HANDLING OF THE INSTRUMENTS, ASEPSIS AND SO ON. THE OPERATING SURGEON IS RESPONSIBLE FOR ANY SUCH COMPLICATIONS OR OTHER CONSEQUENCES." A REVIEW OF THE SURGICAL TECHNIQUE IDENTIFIED UNDER SUBSECTION "NAIL EXTRACTION" THAT "THE CEPHALOMEDULLARY LAG SCREW EXTRACTION DEVICE SHOULD THEN BE ENGAGED AND ROTATED IN A COUNTER-CLOCKWISE MOTION INTO THE EXPOSED LATERAL THREADS OF THE CEPHALOMEDULLARY LAG SCREW THAT IS BEING EXPLANTED". THIS INSTRUCTION IS CONTRARY TO THE REPORTED EVENT, WHERE THE SURGEON REPORTEDLY PUSHED THE LAG SCREW IN THE DIRECTION OF THE EPIPHYSIS, DAMAGING THE ILIOPSOAS MUSCLE AND CAUSING A HEMORRHAGE. BASED ON THE REPORTED EVENT, USER ERROR LIKELY CONTRIBUTED TO THE INTRAOPERATIVE COMPLICATIONS, WHICH CONTRIBUTED TO THE PATIENT'S DEATH. HOWEVER, WITHOUT SURGICAL REPORTS OR OTHER RELEVANT MEDICAL RECORDS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH CM NAIL SYSTEM, PATIENT UNDERWENT EXPLANTED SURGERY APPROXIMATELY 10 MONTHS POST IMPLANTATION. DURING THE SURGERY SURGEON HAD DIFFICULTY REMOVING THE LAG SCREW AND NAIL AND SHOWED A DROP IN BLOOD PRESSURE INTRAOPERATIVELY BUT WAS ABLE TO PULL IT OUT SUCCESSFULLY. POSTOPERATIVE ECHO IMAGING SHOWED BLEEDING IN THE ABDOMINAL CAVITY, AND CT IMAGING REVEALED EVIDENCE THAT THE LAG SCREW HAD PENETRATED THE BONY HEAD. THE OUTER PELVIS WAS PUNCTURED, AND THE INNER PELVIS WAS SLIGHTLY FRACTURED. THE PATIENT WAS RUSHED TO ANOTHER EMERGENCY FACILITY, BUT THE PATIENT DIED ONE DAY AFTER SURGERY. THE CAUSE OF THE HEMORRHAGE WAS ATTRIBUTED TO THE SURGEON'S DIFFICULTY IN REMOVING THE LAG SCREW, WHICH FOR SOME REASON WAS PUSHED IN THE DIRECTION OF THE EPIPHYSIS, DAMAGING THE ILIOPSOAS MUSCLE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022838 CM LAG SCREW RET SHAFT ASIA- TRAUMA, INSTRUMENTS HSB ZIMMER GMBH UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death SEE H11 NARRATIVE