BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 BM HO 12.0

    MDR report key: 5686390 · Received May 27, 2016

    Report

    Report Number
    0001825034-2016-01807
    Event Type
    Injury
    Date Received
    May 27, 2016
    Date of Event
    April 20, 2016
    Report Date
    September 12, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K101086. (B)(4). 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 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-01802 / 01803 / 01806 / 01807).

    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

    (B)(4). VISUALLY EXAMINATION OF THE STEM IDENTIFIED MAJOR SCRATCHES ON THE NECK, TAPER TRUNNION, AND THE STEM COATING SURFACES. THE SCRATCHES ARE LIKELY FROM EXPLANTING THE PRODUCT. THERE IS EVIDENCE OF BONY INGROWTH. THE BONE IS STARTING TO DECAY EVIDENT IN BONE PIECES FALLING OFF THE STEM COATING SURFACE. BONE GROWTH ANALYSIS CANNOT BE PERFORMED AS BONE HAS DECAYED AND IS FLAKING OFF. NO DIMENSIONAL CHECK WILL BE PERFORMED. REVIEW OF MANUFACTURING HISTORY RECORD SHOWED ALL PARTS RELEASED TO DISTRIBUTION WITH NO DEVIATION OR ANOMALIES. THE FAILURE MODE AND ROOT CAUSE FOR INFECTION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION DUE TO INFECTION. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339383 TPRLC 133 TYPE1 BM HO 12.0 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 3487077

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R