BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 12X24 MM IMPLANT HEAD

    MDR report key: 19656324 · Received July 2, 2024

    Report

    Report Number
    0001825034-2024-01742
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    May 13, 2014
    Report Date
    December 3, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    UDI-DI
    00880304438309
    PMA / PMN Number
    K051385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: NORWAY. D10 - MEDICAL PRODUCT: CATALOG #: 11-210041, EXPLOR 10X24 MM IMPLANT HEAD, LOT # 945990. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: B4, B5, D2, D4 (EXP DATE, UDI), G3, H1, H2, H3, H4, H6, H11. IT WAS REPORTED THAT A PATIENT REQUIRED A REOPERATION DUE TO EXCESS BONE FORMATION RESULTING IN STIFFNESS AND REDUCED RANGE OF MOTION. THE IMPLANTS REMAINED INTACT, AND THE COMPLICATIONS RESOLVED AFTER THE BONE REMOVAL. HETEROTOPIC OSSIFICATION (HO) IS THE ABNORMAL AND RAPID GROWTH OF BONE THAT FORMS WITHIN SOFT TISSUE AS THE RESULT OF HEREDITY, TRAUMA, SURGICAL HISTORY, OR DISEASES OF A JOINT. THE RAPID AND IRREGULAR GROWTH OF BONE OFTEN CAUSES A SHARP OR JUTTED STRUCTURE TO FORM, WHICH CAN RESULT IN PAIN AND IRRITATION TO THE SURROUNDING TISSUES, OR THE PATIENT CAN REMAIN ASYMPTOMATIC. RADIATION OR NONSTEROIDAL ANTI-INFLAMMATORY MEDICATIONS ARE OFTEN PROVIDED TO PREVENT HO FORMATION. THE ONLY TREATMENT, IF NECESSARY, IS SURGICAL EXCISION OR SHAVING/SMOOTHING OUT THE EXCESS BONE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WILL NOT BE PERFORMED. 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 · 0

    (B)(4). 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 THE PATIENT EXPERIENCED LOSS OF RANGE OF MOTION AND STIFFNESS 3 MONTHS POST OPERATION. THERE WAS NO SUPINATION, TOTAL ROM 35 DEGREES EXT/FLEX, AND ARTHROSIS OPEN SURGERY WITH BONE EXICISION. THE PATIENT RECEIVED REOPERATION FOR THESE ISSUES. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT DURING THE REOPERATION PROCEDURE, THAT NONE OF THE DEVICES WERE REMOVED. THE PATIENT HAD BONE REMOVED TO RESOLVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800729 EXPLOR 12X24 MM IMPLANT HEAD EXTREMITY IMPLANT KWI ZIMMER BIOMET, INC. N/A 943900 00880304438309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H10.