BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS XTR THK BRNG 24MM

    MDR report key: 6414109 · Received March 17, 2017

    Report

    Report Number
    0001825034-2017-01715
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    February 24, 2017
    Report Date
    May 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT - OSS POLY FEMORAL BUSHINGS 2-PACK CAT#: 150477 LOT#: 988360, OS POLY TIBIAL BUSHING CAT#: 150476 LOT#: 872050, OSS AXLE CAT#: 150480 LOT#: 627000, OSS POLY LOCK PIN CAT#: 150478 LOT#: 645730, OSS X-LONG FINN YOKE 24 MIN POLY CAT#: CP112264 LOT#: 177060. ROOT CAUSE REMAINS UNDETERMINED. 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

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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

    PT IDENTIFIER: - (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT UNDERWENT A CUSTOM RIGHT EXTREMITY ARTHROPLASTY PROCEDURE AND WAS REVISED APPROXIMATELY 11 YEARS POST-OPERATIVELY DUE TO AUDIBLE "CLUNK" SOUNDS WITH MOVEMENT. IT WAS THOUGHT THAT THE POLY WAS BROKEN, BUT UPON REVISION IT WAS DISCOVERED INTACT. BONE RESORPTION WAS ALSO DISCOVERED, REQUIRING LONGER SEGMENTS TO BE IMPLANTED TO ALLOW FOR A SMALLER POLY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194695 OSS XTR THK BRNG 24MM PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A 307930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R