BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET INTERLOK 75MM FIXED I-BEAM TIBIAL PLATE WITH LOCKING BAR

    MDR report key: 5924183 · Received September 2, 2016

    Report

    Report Number
    0001825034-2016-03438
    Event Type
    Injury
    Date Received
    September 2, 2016
    Date of Event
    July 27, 2016
    Report Date
    August 3, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: ITEM: 183014, VANGUARD CR ILOK FEM-RT 75, LOT: 629370; ITEM: 11-150830, AGC PATELLA ARCOM POLY. WITH WIRE 37MM, LOT: 243030; ITEM: 183540, VNGD CR LIP TIB BRG 10X71/75, LOT: 317840.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE REVISION OCCURRED ON THE RIGHT KNEE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 3 YEARS POST-IMPLANTATION DUE TO A LOOSE TIBIAL TRAY.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY 3 YEARS POST-IMPLANTATION DUE TO A LOOSE TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575992 BIOMET INTERLOK 75MM FIXED I-BEAM TIBIAL PLATE WITH LOCKING BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A J2900292

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R