BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STR MOD ACET INSERTER HANDLE

    MDR report key: 6629256 · Received June 9, 2017

    Report

    Report Number
    0001825034-2017-03702
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    May 10, 2017
    Report Date
    September 11, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MDM
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT PRODUCTS: S313142 ZB120201 STRAIGHT MAGNUM INSERTER ¼-20 THREADED ROD KIT, 14-103650 499890 UNIV 2-HOLE SHL 50MM LNR SZ 23, 163669 934820 32MM MOD HD COCR STD, 192409 224820 BI-METRIC ECHO PC RED 9X125. (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: 0001825034 - 2017 - 03701.

    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. AN INSERTER WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE SHAFT OF THE INSERTER IS SCUFFED AND DISCOLORED. VISUAL DAMAGE CAN BE SEEN ON THE THREADS. THE MAJOR DIAMETER AND THREAD DEPTH WERE MEASURED TO BE WITHIN SPECIFICATION. THE THREADS OF THE INSERTER WOULD NOT RECEIVE THE GO THREAD GAGE RING. AN INSERTER HANDLE WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND DAMAGE CONSISTENT WITH A MULTIPLE USE DEVICE. SCUFFING AND SCRATCHING IMPACT MARKS WERE OBSERVED ON THE STRIKE PLATE. THE THREADED INSERTER IS ABLE TO BE ASSEMBLED WITH THE HANDLE. THE THREADS EXTEND FROM THE END OF THE HANDLE FAR ENOUGH TO ALLOW A SHELL TO ENGAGE THE THREADS. DHR (DEVICE HISTORY RECORD) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEFT TOTAL HIP ARTHROPLASTY, THE HANDLE/IMPACTOR COULDN'T CONNECT WELL WITH THE SHELL. THE THREAD OF THE HANDLE WAS LOOSE AND THE SHELL COULDN¿T BE IMPLANTED STABLY CAUSING A SURGERY DELAY OVER 30 MINUTES. A SECOND INSERTER WAS USED TO COMPLETE THE SURGERY. 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
    411229 STR MOD ACET INSERTER HANDLE PROSTHESIS, HIP MDM BIOMET ORTHOPEDICS N/A 126619

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other