BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM-RIGHT

    MDR report key: 6910943 · Received October 3, 2017

    Report

    Report Number
    1000562954-2017-10225
    Event Type
    Injury
    Date Received
    October 3, 2017
    Report Date
    September 14, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    UDI-DI
    07611819189126
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, DOB AND WEIGHT NOT PROVIDED FOR REPORTING. ORIGINAL IMPLANT DATE SOMETIME IN (B)(6) 2012. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THERAPY DATE IS SOMETIME IN (B)(6) 2012. (B)(6). (B)(4). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART# 222.256 LOT#7821675, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 13.MAR.2012. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED AND REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT (B)(6) SUFFERED A MOTORCYCLE ACCIDENT THAT RESULTED IN THE FRACTURE OF HER RIGHT LEG. THE NEED FOR ORTHOPEDIC PROSTHESIS WAS FOUND. A FIRST MEDICAL PROCEDURE WAS PERFORMED WITH THE PLACEMENT OF AN EXTERNAL IMMOBILIZER, WHICH WOULD NOT BE ENOUGH TO REPAIR THE PATIENT'S FRACTURE. THE PATIENT WAS OPERATED ON BY DR. (B)(6) AT THE BEGINNING OF (B)(6) 2012 AT THE HOSPITAL (B)(6), AT WHICH TIME THE PROSTHESIS WAS SCREWED INTO HER KNEE AND RIGHT FEMUR. BONE GRAFT WAS ALSO USED TO STRENGTHEN THE FRACTURED BONE AND TO ACCELERATE THE PROCESS OF CALCIFICATION OF THE LESION. EVEN AFTER FOLLOWING ALL MEDICAL RECOMMENDATIONS DURING THE POSTOPERATIVE PERIOD, THE PROSTHESIS BROKE DURING THE FIRST PHYSIOTHERAPY SESSION OF THE PATIENT. AT THIS TIME, THE PATIENT'S PARENTS REALIZED THAT THE PROSTHESIS SOLD TO THEM WAS MADE OF STEEL AND NOT TITANIUM, ACCORDING TO THE NF ITSELF. ACCORDING TO THE LAWYER OF THE PATIENT SYNTHES WOULD HAVE REFUSED TO SUPPLY A NEW PROSTHESIS AND COST A NEW SURGERY, REQUIRING A FIRST SURGERY TO REMOVE THE PROSTHESIS AND PERFORM A FRACTURE ANALYSIS. THE PATIENT ALSO STATES THAT SHE HAD A SHORTENING OF 2 CM OF HER RIGHT LEG DUE TO THE RUPTURE OF THE PROSTHESIS, EVEN AFTER PERFORMING A NEW BONE GRAFT IN HER FEMUR. ACCORDING TO THE LEGAL DEPARTMENT "THE ACTION WAS PROPOSED BECAUSE OF SYNTHES' ORTHOPEDIC PROSTHESIS RUPTURE." THERE IS 1 DEVICE IN THIS COMPLAINT CONCOMITANT DEVICES REPORTED: SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT SUFFERED A MOTORCYCLE ACCIDENT THAT RESULTED IN THE FRACTURE OF HER RIGHT LEG. THE NEED FOR ORTHOPEDIC PROSTHESIS WAS FOUND. AN INITIAL MEDICAL PROCEDURE WAS PERFORMED WITH THE PLACEMENT OF AN EXTERNAL IMMOBILIZER, WHICH WOULD NOT BE ENOUGH TO REPAIR THE PATIENT'S FRACTURE. THE PATIENT WAS OPERATED ON AT THE BEGINNING OF (B)(6) 2012, AT WHICH TIME THE PROSTHESIS WAS SCREWED INTO HER KNEE AND RIGHT FEMUR. BONE GRAFT WAS ALSO USED TO STRENGTHEN THE FRACTURED BONE AND TO ACCELERATE THE PROCESS OF CALCIFICATION OF THE LESION. EVEN AFTER FOLLOWING ALL MEDICAL RECOMMENDATIONS DURING THE POSTOPERATIVE PERIOD, THE PROSTHESIS BROKE DURING THE FIRST PHYSIOTHERAPY SESSION OF THE PATIENT. THE PATIENT ALSO STATES THAT SHE HAD A SHORTENING OF 2CM OF HER RIGHT LEG DUE TO THE RUPTURE OF THE PROSTHESIS, EVEN AFTER PERFORMING A NEW BONE GRAFT IN HER FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692051 LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM-RIGHT PLATE, FIXATION, BONE HRS SYNTHES MEZZOVICO 7821675 07611819189126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UN