BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP UNI INS SZ3 7MM RMLL AOX

    MDR report key: 23789926 · Received December 12, 2025

    Report

    Report Number
    1818910-2025-21744
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 27, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HRY
    UDI-DI
    10603295501855
    PMA / PMN Number
    K193549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY ACCORDING TO THE INFORMATION RECEIVED, ¿IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCT IN QUESTION. IN THE SURGERY, THE PRODUCT COULD NOT BE INSERTED.¿ THE PRODUCT RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS REVEALED THAT THE IMPLANT EDGES EXHIBIT SIGNS OF DEFORMATION AND SLIGHT SURFACE SCRATCHES, WHICH ARE CONSISTENT WITH ATTEMPTED IMPLANTATION ATTEMPTS. NO OTHER DEFECTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WERE OBSERVED. THE SIGMA® HIGH PERFORMANCE PARTIAL KNEE UNICONDYLAR SURGICAL TECHNIQUE (DSUS/JRC/1114/0582) PROVIDES DETAILED GUIDANCE FOR THE PROPER STEPS REQUIRED TO ACHIEVE CORRECT FINAL IMPLANTATION. ADHERING TO THESE STEPS ENSURES THAT THE INSERT LOCKS SECURELY INTO THE TIBIAL BASE AS INTENDED, THEREBY REDUCING THE RISK OF IMPROPER SEATING AND PREVENTING POTENTIAL DAMAGE TO THE UNI INSERT. THE OBSERVED DAMAGED CONDITION SUGGESTS AN IMPROPER ALIGNMENT WHEN TRYING TO INTRODUCE THE UNI INSERT THROUGH THE TIBIAL BASE LOCKING EDGE. THIS WOULD CONTRIBUTE TO THE DIFFICULTY/INABILITY TO MATE THE INSERT WITH THE TIBIAL COMPONENT FOLLOWING MULTIPLE INSERTION ATTEMPTS. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE MATING DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, DUE TO THE VISUAL DAMAGE OBSERVED, THE DIFFICULTY/INABILITY TO ASSEMBLE MATING DEVICES CAN BE CONFIRMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE HP UNI INS SZ3 7MM RMLL AOX WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT A SEARCH OF THE DEPUY SYNTHES NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. CORRECTED: H3

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES HAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED D9. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H11 ADDITIONAL MANUFACTURER NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INSERT DEVICE COULD NOT BE INSERTED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED, WITHOUT SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2758883 HP UNI INS SZ3 7MM RMLL AOX PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY DEPUY ORTHOPAEDICS INC US M3853T 10603295501855

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown