BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC TRADITION PRIMARY TIBIAL BEARING

    MDR report key: 5922291 · Received September 1, 2016

    Report

    Report Number
    0001825034-2016-03424
    Event Type
    Injury
    Date Received
    September 1, 2016
    Date of Event
    October 18, 2016
    Report Date
    August 3, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK833921
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT PRODUCTS: ITEM: 11-150828, BMET ARCOM AP PAT W/WIRE 34MM: LOT # 405150. ITEM: 152746, AGC ANATOMIC POR FMRL 70 LEFT, LOT # 366660. ITEM: 151020, AGC TRAD PRI TIB BEAR 10X87/91, LOT # 095130. ITEM: 141267, MAXIM POR PRI TIB TRAY 87MM, LOT # 103490. ITEM: 141310, MAX I-BEAM PRIMARY STEM 40MM, LOT # 801080. ITEM: 103532, TI LOW PROFILE SCREW 6.5X25MM, LOT # 076810. ITEM: 103533, TI LOW PROFILE SCREW 6.5X30MM, LOT # 772570. ITEM: 103533, TI LOW PROFILE SCREW 6.5X30MM, LOT # 043220. ITEM: 103535, TI LOW PROFILE SCREW 6.5X40MM, LOT # 450020.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION.

    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 MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 11 STATES, ¿WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE PATIENT WAS REVISED DUE TO POLYETHYLENE WEAR.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR REVISION DUE TO AN UNKNOWN A REASON; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE REVISION PROCEDURE APPROXIMATELY 17 YEARS POST-IMPLANTATION DUE TO POLYETHYLENE WEAR. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573404 AGC TRADITION PRIMARY TIBIAL BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 095130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R