BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRIMARY DCM TIBIAL BEARING 10X63/67 MM WIDE

    MDR report key: 6510757 · Received April 21, 2017

    Report

    Report Number
    0001825034-2017-02706
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    March 15, 2017
    Report Date
    August 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - BIOMET CC CRUCIATE TRAY 67 MM, CATALOG #: 141232, LOT #: UNKNOWN. PALACOS G BONE CEMENT 40 GRAMS, CATALOG #: 424810, LOT #: 003776. BIOMET MAXIM POROUS PRIMARY FEMORAL 60 RT, CATALOG #: 140051, LOT #: 021440. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT COULD NOT BE CONFIRMED. DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. A PHOTOGRAPH OF BEARING WAS PROVIDED BUT DUE TO POOR IMAGE QUALITY, EXAMINATION COULD NOT BE CONDUCTED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION AVAILABLE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THESE TYPES OF EVENTS CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 · 1

    IT WAS REPORTED THAT FOLLOWING AN INITIAL KNEE ARTHROPLASTY, THE PATIENT'S TIBIAL BEARING AND LOCKING BAR WERE REVISED DUE TO PAIN AND WEAR OF THE TIBIAL BEARING. THE PATIENT'S PATELLA WAS NOT RESURFACED DURING THE ORIGINAL SURGERY AND THAT PROCEDURE OCCURRED DURING THE TIBIAL BEARING REVISION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292202 MAXIM PRIMARY DCM TIBIAL BEARING 10X63/67 MM WIDE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 662460

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R