BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CRUCIATE TIBIAL TRAY

    MDR report key: 7363941 · Received March 22, 2018

    Report

    Report Number
    0001825034-2018-02045
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    February 21, 2018
    Report Date
    April 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EP-183660 E1 VNGD PS TIB BRG 79/83X10 173580. 00111214001 PALACOS R 1X40 SINGLE 81454445. 00111314001 PALACOS RG 1X40 SINGLE 81824426. 183132 VAN PS OPEN INTL FEM-LT 70 J3655102. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED X-RAYS AND OP NOTES. REVIEW OF PRE-REVISION FOLLOW-UP RECORDS NOTED PATIENT EXPERIENCING PAIN WITH ACTIVITIES AND INSTABILITY. DISLOCATION OF THE PATELLA AND ALSO NOTED THAT THERE IS NO GROSS MALROTATION ON THE FEMORAL SIDE BUT THERE MIGHT BE INTERNAL ROTATION ON THE TIBIAL SIDE. X-RAYS PROVIDED WERE SENT TO HCP FOR REVIEW. IT WAS NOTED THAT THE PATELLAR COMPONENT WHICH DEMONSTRATED SEVERE LATERAL SUBLUXATION VERSUS DISLOCATION. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD POSTERIOR STABILIZED BEARING, CATALOG #: EP-183660, LOT #: 173580, VANGUARD INTERLOCK FEMORAL, CATALOG #: 183132, LOT #: J3655102, PATELLA, CATALOG #: 184764, LOT # 056770. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02146. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO MALPOSITION OF TIBIAL PROSTHESIS AND DISLOCATION OF THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207238 BIOMET CRUCIATE TIBIAL TRAY PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A J3646481

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R