BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK MAXIMUM CONGRUENT KNEE

    MDR report key: 6396479 · Received March 10, 2017

    Report

    Report Number
    0001825034-2017-01488
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 15, 2017
    Report Date
    October 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER - CMP-(B)(4). MEDICAL PRODUCTS - UNKNOWN CEMENT, AGC PATELLA ARCOM POLY. WITH WIRE 31MM CATALOG #: 11-150826 LOT#: 676180 OR 509430, MAX ILK ANA RF PS FML 60LT VII CATALOG #: 145131 LOT #:390290, BIOMET CC I-BEAM TRAY. 63MM CATALOG #: 141221 LOT#: 455570 OR 005430. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-01515. PRODUCT DISCARDED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS COMPONENT WAS DETERMINED TO BE NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWELVE YEARS POST-OP DUE TO PATIENT FALLING CAUSING THE PATIENT'S PATELLA TO FRACTURE AND THE CEMENT MANTEL TO BE DISRUPTED BETWEEN THE PATELLA POLYETHYLENE AND THE NATIVE BONE. THE POLYETHYLENE AND PATELLA WERE REMOVED AND REPLACED. IT WAS NOTED THERE WAS NO SIGNS OF COMPONENT FAILURE OR EXCESSIVE WEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178292 MCK MAXIMUM CONGRUENT KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 900410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R