BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSP HIP FX PLATING 7.5MM TELESCOPING LAG SCREW

    MDR report key: 6483348 · Received April 11, 2017

    Report

    Report Number
    0001825034-2017-02255
    Event Type
    Injury
    Date Received
    April 11, 2017
    Date of Event
    January 27, 2017
    Report Date
    January 15, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    JDO
    PMA / PMN Number
    PK140018
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. POST OP X-RAYS SHOW THAT THE HARDWARE IS INTACT AND STABLE. DURING THE PATIENTS 3 MONTH POST OP APPOINTMENT, THE PATIENT COMPLAINED OF LOW BACK PAIN AND IT BAND TIGHTNESS. X-RAY WERE TAKEN AND THE HARDWARE IS INTACT, STABLE, AND MAINTAINING GOOD ALIGNMENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02254, 0001825034-2017-02256 AND 0001825034-2017-02257. (B)(4). CONCOMITANT MEDICAL PRODUCTS: TSP HIP FX PLATING 7.5MM TELESCOPING LAG SCREW, CATALOG #: 14-451085, LOT #: 815460; TSP HIP FX PLATING 7.5MM TELESCOPING LAG SCREW, CATALOG #: 14-451080, LOT #: 933380; TSP HIP FX PLATING NECK FRACTURE PLATE, CATALOG #: 14-451002, LOT #: 739700. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR EVALUATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A HIP FRACTURE TRAUMA PLATING PROCEDURE AND BEGAN EXPERIENCING LOW BACK PAIN AND ILIOTIBIAL BAND TIGHTNESS ONSET APPROXIMATELY THREE (3) MONTHS POST-OPERATIVELY. SUBSEQUENTLY, ONE YEAR POST-OPERATIVE FOLLOW-UP NOTED THE PATIENT HAS SOME DIFFICULTY LAYING ON OPERATIVE SIDE, THIGH PAIN, LEG PAIN, AND BACK PAIN. HOWEVER, THE DEVICE WAS NOTED TO BE PERFORMING WELL WITH NO ISSUES NOTED. THE PATIENT WAS HOSPITALIZED AND RECEIVED MEDICATION TO TREAT THE BACK PAIN. THE SURGEON STATED THAT THE LEG PAIN COULD BE RELATED TO THE BACK PAIN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262627 TSP HIP FX PLATING 7.5MM TELESCOPING LAG SCREW DEVICE, FIXATION JDO BIOMET TRAUMA N/A 193960

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R