BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS® SPOTORNO®, STEM, 135°, UNCEMENTED, 9.0, TAPER 12/14

    MDR report key: 21278396 · Received January 30, 2025

    Report

    Report Number
    0009613350-2025-00040
    Event Type
    Injury
    Date Received
    January 30, 2025
    Report Date
    May 30, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024591301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H10, H11.

    Additional Manufacturer Narrative · 0

    (B)(4). D10. COCR HEAD, M, ø 36/0, TAPER 12/14 ITEM# 0101012366 LOT# 3133587. G7 OSSEOTI 4 HOLE SHELL 54MM F ITEM# 110010245 LOT# 7459648. 36MM I.D. SIZE F NEUTRAL LINER ITEM# 20103606 LOT# 65627100. G2. REPORT SOURCE: SWEDEN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT HAS NOT BEEN RETURNED. NO PRODUCT EVALUATION WAS ABLE TO BE COMPLETED. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. 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. 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 A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 2-3 MONTHS POST OPERATIVE BEGAN TO EXPERIENCE PAIN AND AT THE 1 YEAR FOLLOW-UP, RADIOGRAPHIC IMAGING DISPLAYED FEMORAL HETEROTOPIC OSSIFICATION. THE STUDY MANAGER COMMUNICATED THAT THE OSSIFICATION SITE WAS SEEN ON PRE-OPERATIVE IMAGES AND HAS BEEN THROUGH THE COURSE OF RADIOGRAPHIC IMAGING, INCLUDING THE CT SCAN. THE PATIENT IS NOW SCHEDULED TO HAVE AN ULTRASOUND GUIDED INJECTION AT THE OSSIFICATION SITE FOR DIAGNOSTIC PURPOSES. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY ONE YEAR AND THREE MONTHS AGO. SUBSEQUENTLY, APPROXIMATELY 2-3 MONTHS POST-OP, THE PATIENT BEGAN TO EXPERIENCE LEFT SEVERE GROIN PAIN, AND AT THE 1-YEAR FOLLOW-UP, RADIOGRAPHIC IMAGING DISPLAYED FEMORAL HETEROTOPIC OSSIFICATION. PATIENT RETURNS TO THE HOSPITAL FOR AN ULTRASOUND-CONTROLLED INJECTION OF LOCAL ANESTHETIC + CORTICOSTEROID AT THE OSSIFICATION SITE. ALL IMPLANTS CURRENTLY REMAIN IN PLACE. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY ONE YEAR AND THREE MONTHS AGO. SUBSEQUENTLY, APPROXIMATELY 2-3 MONTHS POST-OP, THE PATIENT BEGAN TO EXPERIENCE LEFT SEVERE GROIN PAIN, AND AT THE 1-YEAR FOLLOW-UP, RADIOGRAPHIC IMAGING DISPLAYED FEMORAL HETEROTOPIC OSSIFICATION. THE PATIENT IS AWAITING A CT SCAN. ALL IMPLANTS CURRENTLY REMAIN IN PLACE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088253 CLS® SPOTORNO®, STEM, 135°, UNCEMENTED, 9.0, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH 3139106 00889024591301

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other SEE H11 NARRATIVE.