BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN RH 130 DEG 9MM X 360MM

    MDR report key: 3112362 · Received May 14, 2013

    Report

    Report Number
    0001825034-2013-01498
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. EXAMINATION OF RETURNED PRODUCT FOUND NO EVIDENCE OF FATIGUE FRACTURE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "THE USE OF METALLIC SURGICAL APPLIANCES PROVIDES THE ORTHOPAEDIC SURGEON A MEANS OF BONE FIXATION AND HELPS GENERALLY IN THE MANAGEMENT OF FRACTURES AND RECONSTRUCTIVE SURGERIES. THESE IMPLANTS ARE INTENDED AS A GUIDE TO NORMAL HEALING, AND ARE NOT INTENDED TO REPLACE NORMAL BODY STRUCTURE OR BEAR THE WEIGHT OF THE BODY IN THE PRESENCE OF INCOMPLETE BONE HEALING. DELAYED UNIONS OR NONUNIONS IN THE PRESENCE OF LOAD BEARING OR WEIGHT BEARING MIGHT EVENTUALLY CAUSE THE IMPLANT TO BREAK DUE TO METAL FATIGUE. ALL METAL SURGICAL IMPLANTS ARE SUBJECTED TO REPEATED STRESS IN USE WHICH CAN RESULT IN METAL FATIGUE."

    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, IT STATES, "THE FOLLOWING ARE THE MOST FREQUENT ADVERSE EVENTS AFTER FIXATION WITH ORTHOPAEDIC SCREWS, PLATES, INTRAMEDULLARY NAILS, COMPRESSION HIP SCREWS, PINS AND WIRES: CRACKING OR FRACTURE OF THE COMPONENTS OR LOSS OF FIXATION IN BONE ATTRIBUTABLE TO NONUNION". DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. (NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. ('DEPUY') ON JUNE 16, 2012 ('CLOSING DATE'). PURSUANT TO THE WRITTEN AGREEMENT BETWEEN BIOMET AND DEPUY, BIOMET AGREED TO BE RESPONSIBLE FOR REGULATORY REPORTING FOR EVENTS WHICH OCCURRED AFTER THE CLOSING DATE REGARDLESS OF THE ENTITY THAT ACTUALLY MANUFACTURED THE PRODUCT. BECAUSE THE PRODUCT THAT IS THE SUBJECT MATTER WAS MANUFACTURED BEFORE THE CLOSING DATE, PLEASE BE ADVISED THAT THE SUBJECT PRODUCT WAS MANUFACTURED BY DEPUY AND NOT BIOMET.)

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TRAUMA PROCEDURE APPROXIMATELY 11 MONTHS AGO. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO A FRACTURE AROUND THE LAG SCREW HOLE. THE PATIENT WAS REVISED TO A TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212278 HFN RH 130 DEG 9MM X 360MM ROD, FIXATION HSB BIOMET TRAUMA N/A DMDB1N

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R