BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS NON-MOD TIB PLATE LONG 75

    MDR report key: 5922876 · Received September 1, 2016

    Report

    Report Number
    0001825034-2016-03443
    Event Type
    Injury
    Date Received
    September 1, 2016
    Date of Event
    August 12, 2016
    Report Date
    November 16, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. (B)(4).

    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. 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 3 OF 4 MDRS 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. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. CONCOMITANT PRODUCTS: 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

    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
    572815 OSS NON-MOD TIB PLATE LONG 75 PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 054210

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R