BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT

    MDR report key: 6396483 · Received March 10, 2017

    Report

    Report Number
    0001825034-2017-01515
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 15, 2017
    Report Date
    February 28, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: UNKNOWN CEMENT, MAX PS DCM TIB BRNG 10X63/67MM: CATALOG #: 11-146530, LOT#: 900410. 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 509430, EXPIRATION DATE - JUL 31, 2010, MANUFACTURE DATE ¿ AUG 3, 2005. OR THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 676180, EXPIRATION DATE - AUG 30, 2010, MANUFACTURE DATE ¿ AUG 3, 2005. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-01488. PRODUCT WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS ABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS DETERMINED TO BE DUE TO PATIENT FALL. 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.

    Additional Manufacturer Narrative · 1

    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 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 BEARING AND PATELLA WERE REMOVED AND REPLACED. IT WAS NOTED THERE WERE 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
    178123 ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 676180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R