BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSN ALL POLY PAT PLY 29MM

    MDR report key: 24454299 · Received February 26, 2026

    Report

    Report Number
    0002648920-2026-00029
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 26, 2026
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MBH
    UDI-DI
    00889024643697
    PMA / PMN Number
    K172524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-1032119 D10- MEDICAL PRODUCT PSN FEM CR CMT CCR NRW SZ 7 L, ITEM# 42502006201, LOT# 67592853. PSN TIB NP STM 5 DEG SZ D L, ITEM# 42532006701, LOT# 67480663. PSN MC VE ASF L 11MM 6-7/CD, ITEM# 42512100411, LOT# 67561382. CANARY TIBIAL EXT 14X30MM, ITEM# 43557003014, LOT# 035134. BIOMET BC R 1X40 US, ITEM# 110035368, LOT# AU15AE1603. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 IS EXPERIENCING SEVERE PAIN TO THE POINT OF BEING BROUGHT TO TEARS APPROXIMATELY ELEVEN DAYS POST IMPLANTATION. PATIENT PRESCRIBED A MEDROL DOSEPAK AND CELEBREX TO BE STARTED AFTER MEDROL DOSEPAK FOR CONTINUED MANAGEMENT OF PAIN AND INFLAMMATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517731 PSN ALL POLY PAT PLY 29MM PROSTHESIS, KNEE MBH ZIMMER MANUFACTURING B.V. 67616353 00889024643697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11.