BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE FIXED BEARING PS RIGHT 10 MM HEIGHT

    MDR report key: 14829503 · Received June 27, 2022

    Report

    Report Number
    3007963827-2022-00169
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    May 25, 2022
    Report Date
    August 5, 2022
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    UDI-DI
    00889024246423
    PMA / PMN Number
    K113369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TIBIAL ARTICULAR SURFACE INSERTER: CATALOG#: 42529900100, LOT#: 65040192; TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E: CATALOG#: 42532007102, LOT#: 65235188. CUSTOMER HAS INDICATED THAT PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. 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 HAVE BEEN UPDATED: B4; B5; G3; H2; H6; H10. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS PRODUCT DID NOT CONTRIBUTE TO THE REPORTED EVENT. DURING THE INVESTIGATION, THE ASSOCIATED ARTICULAR SURFACE INSERTER WAS FOUND TO BE MISSING A COMPONENT WHICH WAS LIKELY THE REASON FOR THE REPORTED ARTICULAR SURFACE MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE COMPONENT WOULD NOT PROPERLY SEAT ON THE TIBIAL TRAY. THERE WAS NO SURGICAL DELAY OR PATIENT IMPACT. THE SURGERY WAS COMPLETED WITH A SECOND IMPLANT WITHOUT COMPLICATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044486 ARTICULAR SURFACE FIXED BEARING PS RIGHT 10 MM HEIGHT PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. 42-5299-001-00 65280394 00889024246423

    Patients

    Seq Age Sex Outcome Treatment
    1 Male