BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZNN RFN NAIL

    MDR report key: 23300579 · Received October 15, 2025

    Report

    Report Number
    0001822565-2025-03728
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    April 30, 2018
    Report Date
    March 23, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; B7; D2; D4; G1; G3; G6; H1; H2; H3; H6. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE LOSS OF FRACTURE REDUCTION AND SUBSEQUENT PAIN AND FEMORAL SHORTENING. 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. EVEN WITH THE ADMINISTRATION OF PREVENTIVE MEDICATION, DVTS CAN STILL DEVELOP. AS THE COMPLAINT INDICATED, A POST-OPERATIVE COMPLICATION OCCURRED, AND MEDICAL INTERVENTION WAS REQUIRED FOR TREATMENT. ANY TIME AN EMBOLISM OR THROMBUS FORMS IT CAN BE PRESUMED THAT MEDICAL INTERVENTION IS NECESSARY TO PRECLUDE HARM. THE EVENT WAS NOT CONFIRMED. IF ANY FURTHER INFORMATION 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

    (B)(4). E1: ESTABLISHMENT NAME: (B)(6). G2: FOREIGN: UNITED KINGDOM. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. H6: COMPONENT CODES: MECHANICAL (G04) - IM NAIL. 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 WAS REPORTED THAT A PATIENT EXPERIENCED AN INTRA-OPERATIVE COMPLICATION IN WHICH THE FRACTURE WAS FIXED IN A SHORTENED POSITION, RESULTING IN AN APPROXIMATELY 2 CM LIMB LENGTH DISCREPANCY. POST-OPERATIVELY, THE PATIENT INITIALLY REPORTED PAIN, MUSCLE WEAKNESS, AND REDUCED RANGE OF MOTION OF THE HIP AND KNEE. APPROXIMATELY TWO (2) MONTHS AFTER THEIR INITIAL SURGERY, A DEEP VEIN THROMBOSIS (DVT) WAS REPORTED, AND FEMORAL SHORTENING WAS NOTED, ATTRIBUTED TO COLLAPSE AT THE FRACTURE SITE. CONSERVATIVE MANAGEMENT WAS IMPLEMENTED, INCLUDING PHYSIOTHERAPY AND USE OF AN INSOLE. AT SUBSEQUENT ASSESSMENT AND DISCHARGE, THE PATIENT DEMONSTRATED GOOD RANGE OF MOTION, NO SWELLING, MINIMAL PAIN AT THE FRACTURE SITE, AND THE CONDITION WAS REPORTED AS RESOLVED. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION ON APPROXIMATELY SIX (6) YEARS AGO AS PART OF A PMCF STUDY ON THE AFN AND RFN ZNN (ZIMMER NATURAL NAILS). DURING THE INITIAL IMPLANTATION, IT WAS REPORTED THAT THERE WAS AN INTRA-OPERATIVE COMPLICATION IN WHICH THE FRACTURE WAS FIXED IN A SHORTENED POSITION, RESULTING IN AN APPROXIMATELY 2 CM LIMB LENGTH DISCREPANCY. POST-OPERATIVELY, THE PATIENT INITIALLY REPORTED PAIN, MUSCLE WEAKNESS, AND REDUCED RANGE OF MOTION OF THE HIP AND KNEE. SUBSEQUENTLY, APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION, A DEEP VEIN THROMBOSIS (DVT) WAS REPORTED, AND FEMORAL SHORTENING WAS NOTED, ATTRIBUTED TO COLLAPSE AT THE FRACTURE SITE. CONSERVATIVE MANAGEMENT WAS IMPLEMENTED, INCLUDING PHYSIOTHERAPY AND USE OF AN INSOLE. AT SUBSEQUENT ASSESSMENT AND DISCHARGE, THE PATIENT DEMONSTRATED GOOD RANGE OF MOTION, NO SWELLING, MINIMAL PAIN AT THE FRACTURE SITE, AND THE CONDITION WAS REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY APPROXIMATELY SEVEN (7) YEARS AND EIGHT (8) MONTHS AGO. SUBSEQUENTLY, THE PATIENT DEVELOPED A DVT AND HAD FEMORAL SHORTENING DUE TO THE COLLAPSE OF THE FRACTURE SITE APPROXIMATELY TWO (2) MONTHS AFTER THEIR INITIAL SURGERY. THE PATIENT WAS TREATED WITH AN INSOLE AND THEIR CONDITION IS NOW RESOLVED. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594603 UNKNOWN ZNN RFN NAIL IMPLANT/TRAUMA HSB ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization| O| R