BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE LONG TROCANTERIC NAIL RIGHT, 130, 380 MM, 9 DIA

    MDR report key: 4103071 · Received September 19, 2014

    Report

    Report Number
    0001825034-2014-07822
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    February 12, 2010
    Report Date
    November 25, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    HSB
    PMA / PMN Number
    PK013563
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR EVALUATION. EVALUATION FOUND EVIDENCE TO SUGGEST THAT A DYNAMIC FATIGUE FRACTURE OCCURRED, WHICH WAS NOT CAUSED BY A MATERIAL DEFECT. THE CRACK AT THE SURFACE OF THE TROCHANTER NAIL WAS BROUGHT ABOUT BY DAMAGE, AND CONTINUED TO SPREAD UNDER THE MOVEMENT OF THE PATIENT, UNTIL THE REMAINING LOAD-BEARING CROSS SECTION COULD NO LONGER WITHSTAND THE STRESS AND THUS FAILED DUE TO AN OVERLOAD FRACTURE. 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 OR ACTUALLY SOLD THE PRODUCT TO THE HEALTHCARE PROVIDER. 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.) DEPUY ALSO SOLD THE PRODUCT THAT IS THE SUBJECT MATTER TO THE HEALTHCARE PROVIDER INVOLVED. THIS EVENT WAS PREVIOUSLY REPORTED BY DEPUY ORTHOPAEDICS UNDER MANUFACTURER REPORT NUMBER 1818910-2010-9995. AT THE TIME OF THE INITIAL REPORT, THE DEVICE HAD NOT BEEN EVALUATED.

    Additional Manufacturer Narrative · 1

    PER FDA REQUEST, THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CLARIFICATION. THIS EVENT WAS ORIGINALLY REPORTED UNDER MANUFACTURER REPORT NUMBER 1818910-2010-9995 BY DEPUY ORTHOPEDICS. DEPUY SUBMITTED SUBSEQUENT FOLLOW UP REPORTS ON JANUARY 4, 2011 AND APRIL 9, 2012 UNDER MANUFACTURER REPORT NUMBER 1818910-2010-9995. BIOMET ORTHOPEDICS INC. ACQUIRED DEPUY TRAUMA PRODUCT LINES AND BECAME THE LEGAL MANUFACTURER AT CLOSING ON JUNE 16, 2012. BIOMET ORTHOPEDICS IS NOW RESPONSIBLE FOR COMPLAINT AND REGULATORY REPORTING FOR THE PRODUCT LINES ACQUIRED. A THIRD PARTY DEVICE EVALUATION WAS FORWARDED FROM DEPUY TO BIOMET. ON SEPTEMBER 19, 2014, BIOMET REPORTED THE DEVICE EVALUATION ON MANUFACTURER REPORT NUMBER 1825034-2014-07822. BIOMET DOES NOT HAVE THE CAPABILITY OR LEGAL AUTHORITY TO ELECTRONICALLY SUBMIT REPORTS UNDER THE DEPUY MANUFACTURER NUMBER (B)(4). PLEASE NOTE THAT THE REPORTS SUBMITTED ON 1818910-2010-9995 AND 1825034-2014-07822 ARE FOR THE SAME PATIENT/EVENT. GOING FORWARD, ADDITIONAL INFORMATION WILL BE SUBMITTED UNDER 1825034-2014-07822.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A FRACTURE REDUCTION PROCEDURE ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO FRACTURE OF THE TROCHANTER NAIL. THE TROCHANTER NAIL WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTS PATIENT UNDERWENT AN OPEN REDUCTION ON THE RIGHT HIP DUE TO A DISLOCATED SUBTROCHANTERIC FRACTURE ON (B)(6) 2009. ADDITIONAL MEDICAL RECORDS NOTED PATIENT UNDERWENT AN ADDITIONAL REVISION ON (B)(6) 2010 DUE TO PAIN AND PSEUDARTHROSIS OF THE FEMUR AND FRACTURE OF THE TROCHANTER NAIL. THE TROCHANTER NAIL WAS REMOVED AND REPLACED WITH A PROXIMAL FEMORAL LOCKING NAIL.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A FRACTURE REDUCTION PROCEDURE ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO FRACTURE OF THE TROCHANTER NAIL. THE TROCHANTER NAIL WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582352 ACE LONG TROCANTERIC NAIL RIGHT, 130, 380 MM, 9 DIA ROD, FIXATION HSB DEPUY ORTHOPAEDICS, INC N/A W87AE7

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R