BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA HEX HEADED SCREW 3.5 MM HEX 27 MM LENGTH

    MDR report key: 21818499 · Received April 10, 2025

    Report

    Report Number
    0001822565-2025-00978
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 25, 2025
    Report Date
    July 15, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: LOT NUMBER: 66219699; 66840941; 66840945. G2 : FOREIGN COUNTRY: JAPAN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; D4; G1; G3; G6; H1; H2; H3; H4; H6. D4 : POTENTIAL EXPIRATION DATES & UDIS FOR EACH POTENTIAL LOT. LOT 66219699 . EXPIRE DATE: 2033-08-26. UDI: (B)(4). LOT 66840941. EXPIRE DATE: 2034-10-20. UDI: (B)(4). LOT 66840945. EXPIRE DATE: 2034-11-25. UDI: (B)(4). H4: POTENTIAL MANUFACTURING DATES FOR EACH POTENTIAL LOT. LOT 66219699 . MANUFACTURE DATE: 2023-08-29. LOT 66840941 . MANUFACTURE DATE: 2024-10-22. LOT 66840945. MANUFACTURE DATE: 2024-11-27. THE EVENT IS CONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS OF THE POTENTIAL LOT NUMBERS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED A TOTAL KNEE ARTHROPLASTY WITH SINGLE SCREW ALONG THE LATERAL TIBIAL PLATEAU. SUBCUTANEOUS EMPHYSEMA DIFFUSELY. VASCULAR CALCIFICATION. NO BONY FRACTURE. OPERATIVE NOTES WERE NOT PROVIDED. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USE ERROR VIA A FAILURE TO FOLLOW INSTRUCTIONS. PER THE SURGICAL TECHNIQUE, 3.5MM HEX HEADED SCREWS CAN BE USED FOR TEMPORARY FIXATION OF THE TIBIAL SIZING PLATE FOR TIBIAL TAPERED STEM PREPARATION, TEMPORARY FIXATION OF THE DRILL GUIDE DURING TIBIAL CENTRAL CONE PREPARATION, AND TEMPORARY FIXATION OF THE DRILL GUIDE DURING FEMORAL CENTRAL CONE PREPARATION. THE TECHNIQUE DOES NOT CALL FOR UTILIZING SCREWS FOR TEMPORARY OR PERMANENT FIXATION OF THE TIBIAL PLATE IMPLANT DURING THE PROCEDURE. ADDITIONALLY, THE HEX HEADED SCREW IS AN INSTRUMENT AND NOT INTENDED TO BE IMPLANTED. THEREFORE, THE USER DID NOT FOLLOW INSTRUCTIONS BY USING HEX HEADED SCREWS FOR FIXATION OF THE TIBIAL PLATE IMPLANT; HOWEVER, IT IS UNCLEAR HOW THIS SCREW WAS USED WITH THE TIBIAL PLATE AS THERE ARE NO THRU HOLES IN THE IMPLANT FOR FIXATION. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2 THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE OF THE THREE HEX HEADED SCREWS USED DURING SURGERY TO FIX THE TIBIAL BASEPLATE WAS MISTAKENLY LEFT INSIDE THE PATIENT'S KNEE. THE SURGEON AND SURGICAL STAFF WERE UNAWARE THAT THE SCREW WAS STILL THERE WHEN THEY CLOSED. THE PATIENT HAS NOT EXPERIENCED ANY POST-OP SYMPTOMS OR COMPLICATIONS. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION HAS BEEN TAKEN. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE SCREW WAS BEING USED TO FIX THE TIBIAL PLATE IMPLANT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471066 PERSONA HEX HEADED SCREW 3.5 MM HEX 27 MM LENGTH INSTRUMENT, KNEE LXH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other