BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HP UNI INS SZ2 7MM RMLL AOX

    MDR report key: 22965333 · Received September 4, 2025

    Report

    Report Number
    1818910-2025-15221
    Event Type
    Injury
    Date Received
    September 4, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HRY
    UDI-DI
    10603295501800
    PMA / PMN Number
    K193549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. ADDED: B5

    Description of Event or Problem · 0

    THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE INITIAL SURGERY AND PAIN AFTER THE SURGERY. THIS PC REPORTS ABOUT THE REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA UKA FOR OA ON MEDIAL CONDYLE OF RIGHT KNEE WITH THE PRODUCTS IN QUESTION. IN THE INITIAL SURGERY, A STANDARD HPP INTUITION MACHINE WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE INITIAL SURGERY, DURING A POSTOPERATIVE VISIT, THE PATIENT COMPLAINED OF PAINFUL DISCOMFORT. WHEN THE KNEE WAS EXTENDED AFTER DEEP FLEXION, THERE WAS A SYMPTOM LIKE A CRACKING SOUND. THAT SYMPTOM DID NOT OCCUR WHEN THE EXTENSION WAS PERFORMED FROM INTERMEDIATE FLEXION. IT WAS THOUGHT THAT THE INSERT WAS NOT DISLODGED, BUT RATHER THAT THE SOFT TISSUE WAS IMPINGING SOMEWHERE. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. AFTER REMOVING THE INSERT AND CHECKING THE SOFT TISSUE, A CEMENT FRAGMENT WAS EXTRACTED FROM THE REAR (THE CEMENT WAS OTHER COMPANIES' PRODUCTS). THIS WAS THOUGHT TO BE THE CAUSE, BUT IT WAS DISCOVERED THAT THE FE IMPLANT HAD LOOSENED, AND IT WAS REMOVED USING A KOCHER CLAMP. USING A 3-IN-1 CUT BLOCK (SRI), INSERT TWO BLOCK STABILIZERS INTO THE PEG HOLES, SECURE THEM WITH SHORT THREAD PINS, RECUT, AND PERFORM PEG REAMING. TRIAL CONDUCTED WITH SIZE 2, 9MM INSERT. THE IMPLANT FE SIZE 2 WAS FIXED WITH BIOMET BONE CEMENT (40G), AND AN 8MM TRIAL INSERT WAS USED. AFTER HARDENING, AN 8MM INSERT WAS IMPLANTED, AND AFTER CONFIRMING THAT THERE WERE NO CRACKS, THE WOUND WAS CLOSED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL EVENT INFORMATION RECEIVED: 1. PLEASE CONFIRM THE AFFECTED SIDE. RIGHT KNEE MEDIAL CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675781 HP UNI INS SZ2 7MM RMLL AOX KNEE IMPLANT - TIBIAL INSERT HRY DEPUY IRELAND - 9616671 M3254P 10603295501800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention