BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL INSERTER/EXTRACTOR

    MDR report key: 6615350 · Received June 6, 2017

    Report

    Report Number
    0001825034-2017-03621
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    May 8, 2017
    Report Date
    June 28, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWB
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE INSERTER CONFIRMED THE TIP IS FRACTURED. THE FRACTURED PORTION REMAINS ASSEMBLED WITH THE RETURNED STEM. THE HANDLE OF THE INSERTER IS CRACKED. IMPACT MARKS ON THE STRIKE PLATE AND SCRATCHES OBSERVED ON THE SHAFT ARE CONSISTENT WITH A MULTIPLE USE INSTRUMENT. THE HARDNESS WAS MEASURED AND IS CONFORMING ACCORDING TO THE PRINT SPECIFICATIONS. THE DEVICE WAS MANUFACTURED IN JANUARY 2014 WITH ALMOST 3.5 YEARS OF FIELD SERVICE AGE. IT IS UNKNOWN HOW MANY TIMES THE DEVICE WAS USED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 192111 833300 BI-METRIC ECHO PC LAT 11X135. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INSERTING THE STEM INSERTER DURING AN INITIAL HIP PROCEDURE, THE TIP IF THE INSERTED BROKE OFF INTO THE IMPLANT. 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
    396090 UNIVERSAL INSERTER/EXTRACTOR PROSTHESIS, HIP HWB BIOMET ORTHOPEDICS N/A ZB140103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other