BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X31-400010 578440 EXACT/ ALLIANCE BROACH PROVISIONAL 10X 130MM

    MDR report key: 6610983 · Received June 5, 2017

    Report

    Report Number
    0001825034-2017-03598
    Event Type
    Malfunction
    Date Received
    June 5, 2017
    Report Date
    August 17, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWT
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. A 10MM BROACH, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE TEETH OF THE BROACH TO BE WORN FROM REPEATED USE OVER THE LIFETIME OF THE INSTRUMENT. THE DEVICE WAS MEASURED ACCORDING TO THE CORRESPONDING INSPECTION. ALL MEASURED CRITERIA WERE FOUND TO BE WITHIN SPECIFICATION. THE BROACHES ARE MANUFACTURED WITH A FIELD SERVICE AGE OF AROUND 11 YEARS. IT IS UNKNOWN HOW MANY TIMES THEY ARE USED AND WEAR IS SEEN ON THE TEETH OF THE RASP. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CONCOMITANT PRODUCT(S): X180439 265610 BI-METRIC XR-SERIES HIP SYSTEM FEMORAL STEM 131.5 NECK. X180410 279620 BI-METRIC XR-SERIES HIP SYSTEM FEMORAL STEM 131.5 NECK. X31-400009 132940 EXACT/ ALLIANCE BROACH PROVISIONAL 9MM X 125MM STAINLESS STEEL/ TITANIUM NITRIDE. A 163662 561040 28MM MOD HD STD NECK TP1 TAPER. REPORT SOURCE: COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2017 - 03829, 0001825034 - 2017 - 03597.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY OPERATION THE SURGEON INSERTED A 9MM STEM IMPLANT INTO PATIENT'S MEDULLARY CAVITY. THE IMPLANT COULD NOT BE NEATLY FIT WITH THE CAVITY EVEN THOUGH THE SURGEON USED A RASP OF THE SAME IMPLANT SIZE. THE STEM WAS PROTRUDED BY A FEW MILLIMETERS FROM THE PROXIMAL FEMUR. THE SURGEON THEN TRIED THE INSERTION WITH 10MM STEM. AFTER THE SURGEON RASPED THE CAVITY WITH 10MM RASP HOWEVER, THE SAME PROBLEM OCCURRED AGAIN. SUBSEQUENTLY, ANOTHER 10MM STEM WAS USED TO COMPLETE THE PROCEDURE. 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
    392355 X31-400010 578440 EXACT/ ALLIANCE BROACH PROVISIONAL 10X 130MM PROSTHESIS, HIP HWT BIOMET ORTHOPEDICS N/A 578440

    Patients

    Seq Age Sex Outcome Treatment
    1