BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS FINN MOD PROX FMRL RT 7CM

    MDR report key: 15224923 · Received August 15, 2022

    Report

    Report Number
    0001825034-2022-01826
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    July 6, 2022
    Report Date
    November 30, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304239784
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: JAPAN. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS & MDRS. 150466 OSS 7CM DIAHPYSEAL SEGMENT LOT# 944580. MDR: 0001825034-2022-01827.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. A SINGLE X-RAY WAS PROVIDED HOWEVER IT WAS NOT SENT FOR FURTHER EVALUATION AS IT WOULD NOT ENHANCE THE INVESTIGATION. MEDICAL RECORDS WERE NOT PROVIDED. IT WAS REPORTED THE SURGEON DID NOT INSERT THE LOCKING SCREW INTO THE PROXIMAL FEMORAL AND DIAPHYSEAL SEGMENT. AS STATED IN THE SURGICAL TECHNIQUE, 'AFTER THE PROXIMAL FEMORAL COMPONENT HAS BEEN IMPACTED WITH THE STEM CONSTRUCT, INSERT THE LARGE HEAD/LARGE THREAD LOCKING SCREW PACKAGED WITH THE SEGMENT, THROUGH THE PROXIMAL FEMORAL COMPONENT AND TIGHTEN'. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO THE USER FAILING TO FOLLOW INSTRUCTIONS. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 THE PATENT UNDERWENT REVIION SURGERY ONE MONTH POST IMPLANTATION. THE SURGEON FOUND DURING REVISION SURGERY, HE FORGOT TO INSERT THE 'LARGE LOCKING SCREW' FOR COMPONENTS FIXATION.

    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
    2346266 OSS FINN MOD PROX FMRL RT 7CM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 374140 00880304239784

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R