BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA FEMORAL IMPACTOR

    MDR report key: 23693567 · Received December 2, 2025

    Report

    Report Number
    0001822565-2025-04350
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 5, 2025
    Report Date
    February 24, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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; H2; H3; H6; THE FOLLOWING SECTIONS WERE CORRECTED: D1; D3; E1. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. DEVICE IS USED FOR TREATMENT. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. COMPLAINT IS NOT CONFIRMED. SUGGESTED COMPONENT CODE: MECHANICAL (G04) - IMPACTOR. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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

    (B)(4). D10: 42-5400-000-35, PSN ALL POLY PAT PLY 35MM, 67498634, 42-5570-001-14, PSN TPR ST 14 X +30 MM, 67468994, 42-5706-068-01, PSN FEM PS CMT TIN STD SZ 10L, 64826045, 42-5126-008-14, PSN ASF CPS 14MM VE L 10-11 EF, 65234839, 42-5320-075-01, PSN TIB STM 5 DEG SZ F L 67329084, 98-0002-002-85, PSN NS FM/CM TB/CPS/PE PSN PT/STM, UNKNOWN LOT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: UPDATED: A1; A3; 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMORAL IMPACTOR BROKE DURING IMPLANTATION. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY, THERE WERE NO FOREIGN BODIES RETAINED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899719 PERSONA FEMORAL IMPACTOR INSTRUMENT, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.