BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D

    MDR report key: 11615724 · Received April 5, 2021

    Report

    Report Number
    3007963827-2021-00080
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 3, 2021
    Report Date
    May 13, 2021
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    K172524
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED VIA COMPATIBILITY CHECK. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY AND IT WAS DETERMINED THAT THE FOLLOWING IMPLANTS ARE NOT COMPATIBLE: LEFT-SIDED TIBIAL PLATE AND LEFT-SIDED ARTICULAR SURFACE USED WITH RIGHT-SIDED FEMORAL IMPLANT IN THE RIGHT KNEE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE REPORTED ISSUE DUE TO THE SURGEON NOT FOLLOWING THE INSTRUCTION. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3007963827-2021-00080 AND 0001822565-2021-00964 . MEDICAL DEVICES: ARTICULAR SURFACE FIXED BEARING PS LEFT 10 MM HEIGHT CATALOG#: 42511400510 LOT#: UNK. FEMUR CEMENTED POSTERIOR STABILIZED (PS) NARROW RIGHT SIZE 6 CATALOG#: 42500006002 LOT#: 63897746. SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TIBIAL INSERT AND TRAY INTENDED FOR A LEFT KNEE WERE IMPLANTED IN A RIGHT KNEE. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512954 TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64761364

    Patients

    Seq Age Sex Outcome Treatment
    1