BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 7CM SEG ELLIPT FEMORAL LT

    MDR report key: 5756989 · Received June 28, 2016

    Report

    Report Number
    0001825034-2016-02345
    Event Type
    Injury
    Date Received
    June 28, 2016
    Date of Event
    August 12, 2016
    Report Date
    August 30, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DEVICE REMAINS IMPLANTED.

    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. 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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION." THIS REPORT IS NUMBER 1 OF 4 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-02345, 03442, 03443, 03445). NOT RETURNED BY PATIENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCT-BIOMET ACROM PATELLA SINGLE 1/4 INCH PEG WITH WIRE CATALOG#11-150826 LOT# 318320, BIOMET OSS TIBIAL BUSHING CATALOG#: 150476 LOT#: 984370, BIOMET OSS FEMORAL BUSHINGS CATALOG#: 150477 LOT#: 958490, BIOMET OSS LOCKING PIN CATALOG#: 150478 LOT#: 531890, BIOMET OSS 12 MM TIBIAL BEARING CATALOG#: 150410 LOT#: 601720.

    Description of Event or Problem · 1

    A PATIENT WHO UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY HAS BEEN INDICATED FOR REVISION DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY NINE MONTHS POST-IMPLANTATION DUE TO A NICKEL AND BONE CEMENT ALLERGY. ALL COMPONENTS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410371 OSS 7CM SEG ELLIPT FEMORAL LT PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 593110

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R