BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDULLARY PLUG W/OUT DRAIN 6

    MDR report key: 22577567 · Received July 23, 2025

    Report

    Report Number
    0009613350-2025-00618
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    June 23, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWA
    UDI-DI
    00889024515222
    PMA / PMN Number
    K974749
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: REPORT SOURCE ITALY. 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, B5, B7, D10, G3, G6, H2, H3, H6, H11. D10: ITEM # UNKNOWN, UNKNOWN CERCLAGE WIRES, LOT # UNKNOWN. ITEM # UNKNOWN, UNKNOWN STEM, LOT # UNKNOWN. ITEM # UNKNOWN, UNKNOWN HEAD, LOT # UNKNOWN. ITEM # UNKNOWN, UNKNOWN CEMENT, LOT # UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL/RADIOLOGIST. THE REVIEW IDENTIFIED THE FOLLOWING: DIFFICULTY INSERTING BIOMET CAP DUE TO RIGIDITY, CAP BECAME STUCK IN FEMORAL CANAL, ¿IN ORDER TO RELEASE, IT WAS NECESSARY TO PUSH HARD WITH A METAL HAMMER CAUSING A PARTIAL FRACTURE OF THE FEMUR DISTALLY TO THE IMPLANT. AN INCISION WAS MADE AT THE LEVEL OF THE FRACTURE TO EXPOSE THE SITE. THE CAP WAS COMPLETELY REMOVED ALONG WITH PART OF THE DISTAL CEMENT. THE FRACTURE WAS THEN REDUCED AND STABILIZED USING CERCLAGE WIRES, ACHIEVING SATISFACTORY SYNTHESIS AND STABILITY. THE SURGICAL SITE WAS CLOSED IN LAYERS, AND THE PROCEDURE REQUIRED AN ADDITIONAL ONE HOUR AND THIRTY MINUTES. SINGLE AP VIEW OF THE RIGHT FEMUR. RIGHT TOTAL HIP ARTHROPLASTY WITH CEMENTED FEMORAL STEM. PERIPROSTHETIC FEMORAL DIAPHYSIS OBLIQUE FRACTURE AT THE DISTAL ASPECT OF THE FEMORAL STEM, EXTENDING TO THE LATERAL FEMORAL CORTEX. THERE ARE 3 CERCLAGE WIRES AROUND THE DIAPHYSIS SPANNING THE FRACTURE SITE. LATERAL SKIN STAPLES, DRAIN AND SOFT TISSUE AIR INDICATE RECENT POST-OPERATIVE STATUS. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO PRECISELY DETERMINE THE CAUSE OF THE REPORTED EVENT. VARIOUS FACTORS MAY HAVE CONTRIBUTED, INCLUDING OPERATIONAL FACTORS AND/OR PATIENT FACTORS. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT 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 DURING THE INSERTION OF THE CEMENT PLUG, BEING IT TOO RIGID, POORLY ADAPTABLE AND WITH A POORLY SEALING HANDLE, IT GOT STUCK IN THE FEMORAL CANAL AND, TO OBTAIN ITS UNBLOCKING, IT WAS NECESSARY TO PUSH FORCEFULLY WITH A METAL BEATER, CAUSING A PARTIAL FRACTURE OF THE FEMUR DISTAL TO THE IMPLANT. SUBSEQUENTLY, THE FRACTURE HAD TO BE SYNTHESIZED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    INITIAL UNKNOWN RIGHT HIP PROCEDURE WAS PERFORMED. IT WAS REPORTED THAT DURING THE INSERTION OF THE CAP FOR CEMENT, THE CAP GOT STUCK IN THE FEMORAL CANAL. IN ORDER TO RELEASE THE CAP, THE CAP HAD TO BE PUSHED HARD WITH A METAL HAMMER CAUSING A PARTIAL FRACTURE OF THE DISTAL FEMUR. THE FRACTURE WAS REDUCED WITH CERCLAGE WIRES. 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
    2752967 MEDULLARY PLUG W/OUT DRAIN 6 PROSTHESIS, HIP HWA ZIMMER GMBH 3228735 00889024515222

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Unknown Required Intervention SEE H11 NARRATIVE.