BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STR INSERTER 1/4-28 THRD KIT

    MDR report key: 6580869 · Received May 21, 2017

    Report

    Report Number
    0001825034-2017-03393
    Event Type
    Injury
    Date Received
    May 21, 2017
    Date of Event
    April 25, 2017
    Report Date
    June 1, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    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)(4). CONCOMITANT PRODUCT(S): S313141 119882 STR MOD ACET INSERTER HANDLE. A 14-103648 485440 UNIV 2-HOLE SHL 48MM LNR SZ 22. 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: 0001825034 - 2017 - 03394.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. UPON RETURN, THE TIP OF THE INSERTER REMAINS IN THE THREADED HOLE OF THE SHELL. THE DEVICE EXHIBITS WEAR AND TEAR THAT INDICATES THE DEVICE FUNCTIONED AS INTENDED DURING ITS POTENTIAL FIELD AGE OF APPROXIMATELY 5 YEARS. DAMAGE ON THE HANDLE LIKELY OCCURRED DURING THE REMOVAL OF THE INSTRUMENT FROM THE SHELL DURING THE EVENT OR FROM PRIOR USES. THE FREQUENCY OF USE OF THE REPORTED DEVICE IS UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT THA DUE TO HIP OSTEOARTHRITIS. DURING IMPLANTATION OF THE CUP, THE HANDLE FRACTURED, THE THREAD FRACTURE COULDN¿T BE RETRIEVED FROM THE CUP. IN ORDER TO COMPLETE THE SURGERY, THE SURGEON THEN REMOVED THE CUP AND REPLACED IT. A 20 MINUTE DELAY WAS CAUSED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361943 STR INSERTER 1/4-28 THRD KIT PROSTHESIS, HIP LXH BIOMET ORTHOPEDICS N/A ZB120201

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other