BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 80 MM TIBIAL PIN

    MDR report key: 14450603 · Received May 20, 2022

    Report

    Report Number
    0009617840-2022-00022
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 19, 2022
    Report Date
    September 20, 2022
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT:(B)(4). COMMENTS: MMI FINAL REPORT RECEIVED ON MAY 2, 2022, AND ATTACHED TO XRAYS WITHIN THE COMPLAINT. SIGNIFICANT FINDINGS INCLUDE: TINY METALLIC FOREIGN BODY WITHIN THE MID TIBIA CONSISTENT WITH THE REPORTED PIN TIP FRACTURE. AN INVESTIGATION INTO THIS INCIDENT IS CURRENTLY UNDERWAY. ONCE THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE MADE AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS NOT RETURNED TO THE PRODUCT SURVEILLANCE TEAM FOR FURTHER EVALUATION, BOTH PART AND LOT NUMBERS WERE UNABLE TO BE PROVIDED BY THE SITE AFTER MULTIPLE FOLLOW UP ATTEMPTS. THE CONTACT WAS ABLE TO PROVIDE X-RAYS OF THE PATIENT'S KNEE FOLLOWING THE SURGERY. X-RAYS WERE REVIEWED BY A SUBJECT MATTER EXPERT AND IT WAS OBSERVED THAT A TINY METAL FRAGMENT COULD BE FOUND WITHIN IN THE MID TIBIA CONSISTENT WITH THE REPORTED PIN TIP FRACTURE. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED WITH THE INFORMATION AVAILABLE. 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 THAT DURING A TKA SURGERY USING ROBOTIC SURGICAL INSTRUMENTATION, A TIBIAL TRACKER PIN BROKE IN THE TIBIA AND A FRAGMENT WAS RETAINED IN THE PATIENT'S BODY. AT THIS TIME THERE IS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487687 UNKNOWN 80 MM TIBIAL PIN ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other