BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PIN

    MDR report key: 16113105 · Received January 6, 2023

    Report

    Report Number
    0009617840-2023-00001
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    May 31, 2022
    Report Date
    April 18, 2023
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PIN REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G3, H2, H3, H6 AN X-RAY PICTURE WAS PROVIDED AND SHOWED THE FOLLOWING: THE RIGHT KNEE ARTHROPLASTY IMPLANTS ARE ANATOMICALLY ALIGNED. THERE IS NO FRACTURE OR DISLOCATION. THERE IS NO EVIDENCE OF IMPLANT LOOSENING. ON THE LATERAL VIEW, THERE IS AN APPARENT FEMORAL PIN FRACTURE FRAGMENT WELL ABOVE THE PROSTHESIS. THIS CORRELATES WITH THE REPORTED PATIENT EVENT. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE ROOT CAUSE OF THE BROKEN PIN COULD NOT BE DETERMINED PRECISELY WITH THE INFORMATION AVAILABLE. POSSIBLE CONTRIBUTING FACTORS ARE EXCESSIVE FORCE AND/OR OFF-ANGLE APPLICATION DURING INSERTION/REMOVAL. 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 · 0

    IT WAS REPORTED DURING A KNEE ARTHROPLASTY, A ROSA TRACKER PIN BROKE AND WAS LEFT IN THE BONE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438580 UNKNOWN PIN INSTRUMENT OLO ZIMMER CAS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other