BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PIN

    MDR report key: 10587108 · Received September 25, 2020

    Report

    Report Number
    0009617840-2020-00005
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    August 12, 2020
    Report Date
    November 11, 2021
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: B4, B5, G3, H1, H2, H3, H6, H10. TECHNICAL EVALUATION COULDN¿T BE PERFORMED AS THE PINS USED DURING THE REPORTED EVENT WERE NOT RETURNED TO ZIMMER BIOMET FOR EVALUATION. THE IMPLANTING SURGEON DICTATED THAT THE ROBOTIC GUIDING PINS WERE PLACED ANTERIOR TO POSTERIOR 4 FINGERBREADTHS ABOVE THE SUPERIOR POLE OF THE PATELLA WHICH IS CONSISTENT WITH THE SURGICAL TECHNIQUE, HOWEVER, THE PIN ITEM AND LOT NUMBERS ARE NOT AVAILABLE SO IT CANNOT BE VERIFIED WHETHER THE PINS USED ARE RECOMMENDED WITH THE USE OF THE ROSA KNEE SYSTEM. VISUAL REVIEW OF THE X-RAYS PROVIDED BY THE USER CONFIRMED THAT THERE IS A FRACTURE ON THE FEMORAL BONE OF THE IMPLANTED LEG, CONFIRMING THE REPORTED EVENT. THE LOWER FRACTURE CORRELATES APPROXIMATELY TO THE LOCATION OF PIN INSERTION BUT THE MAJOR FRACTURE OFFSET IS MUCH MORE PROXIMAL. REVIEW OF THE DHR COULD NOT BE PERFORMED BECAUSE ITEM AND LOT NUMBERS ARE UNAVAILABLE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MEDICAL RECORDS WERE RECEIVED AND THE REPORTED EVENT UPDATED, HOWEVER, THIS INFORMATION DID NOT EFFECT OR CHANGE THE PREVIOUS INVESTIGATION RESULTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT IS EXPERIENCING NONUNION OF THE FEMORAL FRACTURE AND WILL UNDERGO A BONE GRAFTING AND ORIF.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION OF HE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A TRANSVERSE FEMUR FRACTURE AT THE SITE OF A NAVITRACKER FIXATION PIN. THE PATIENT HAD A RETROGRADE FEMORAL NAIL PLACED. NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053755 UNKNOWN PIN PIN OLO ZIMMER CAS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention