BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSN ASF PS 14MM VE R 10-12 GH

    MDR report key: 23574353 · Received November 17, 2025

    Report

    Report Number
    3007963827-2025-00464
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 30, 2025
    Report Date
    April 7, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024244030
    PMA / PMN Number
    K121771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, H2, H6. THE FOLLOWING SECTION WAS CORRECTED: H4. THE REPORTED EVENT WAS CONFIRMED VIA PRODUCT RETURN. VISUAL INSPECTION OF THE RETURNED BEARING EXHIBITED SIGNS OF USE AND PITTING ON THE SURFACE. DEVICE ALSO SHOWED SOME DAMAGE ON THE DOVETAIL, LIKELY CAUSED DURING EXPLANTATION. ANALYSIS OF THE RETURNED DEVICE INDICATES THAT THE OBSERVED DAMAGE IS UNLIKELY TO HAVE DEVELOPED WITHIN 48 HOURS OF IMPLANTATION; HOWEVER, THIRD-BODY DEBRIS MAY ACCOUNT FOR THE OBSERVED PITTING. BASED ON FURTHER ANALYSIS, THE OBSERVED PITTING APPEARS TO HAVE OCCURRED AFTER THE MACHINING PROCESS AND DOES NOT APPEAR TO BE ATTRIBUTABLE TO THE MANUFACTURING PROCESS. THE FINDINGS FURTHER SUGGEST THAT THE PITS MAY BE CONSISTENT WITH IMPACT-RELATED DAMAGE, POTENTIALLY ASSOCIATED WITH A FALL. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NO MEDICAL RECORDS WERE PROVIDED. IT WAS REPORTED THAT THE PATIENT FELL, HOWEVER THE CAUSE OF THE FALL IS UNKNOWN. THE ROOT CAUSE FOR THE WOUND DEHISCENCE WAS DETERMINED TO BE UNRELATED TO THE DEVICE. THE ROOT CAUSE FOR WEAR CANNOT BE DETERMINED. 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). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A WASHOUT AND POLYETHYLENE INSERT EXCHANGE APPROXIMATELY 2 DAYS POST-IMPLANTATION FOLLOWING A FALL WITH WOUND DEHISCENCE. A WASHOUT PROCEDURE WITH POLYETHYLENE INSERT EXCHANGE WAS PERFORMED. UPON REMOVAL, THE POLYETHYLENE INSERT WAS OBSERVED TO HAVE PITTING ON THE MEDIAL AND LATERAL CONDYLES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2875455 PSN ASF PS 14MM VE R 10-12 GH PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 65546205 00889024244030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.