BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 LONGEVITY NEUTRAL 36MM F

    MDR report key: 21154899 · Received January 14, 2025

    Report

    Report Number
    0001822565-2025-00128
    Event Type
    Injury
    Date Received
    January 14, 2025
    Report Date
    April 15, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024518759
    PMA / PMN Number
    K190660
    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. PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 0101012366 LOT# 3133587 COCR HEAD, M, ø 36/0, TAPER 12/14. CAT# 290039090 LOT# 3139106 CLS SPOTORNOÂ, STEM,135°, UNCEMENTED, 9.0, TAPER 12/14. CAT# 110010245 LOT# 7459648 G7 OSSEOTI 4 HOLE SHELL 54MM F. G2: FOREIGN: COUNTRY: SWEDEN. PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;B5;G3;H2;H3;H6. PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; G3; H2; H3; H6. THE FOLLOWING SECTION WAS UPDATED: H4. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SEVERE GROIN PAIN. RADIOGRAPHS WERE PROVIDED; HOWEVER, BASED ON THE REPORTED INFORMATION, THEY WOULD NOT ENHANCE THE INVESTIGATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT WAS CONFIRMED BASED ON THE MEDICAL RECORD FINDINGS. 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

    ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT THE PATIENT¿S OSSIFICATION SITE WAS SEEN ON PRE-OPERATIVE IMAGES AND THE PATIENT HAS BEEN THROUGH THE COURSE OF RADIOGRAPHIC IMAGING, INCLUDING A RECENT CT SCAN COMPLETED APPROXIMATELY TWO MONTHS AGO. IT WAS REPORTED THAT THERE WAS NO TRAUMA OR OTHER SPECIFIC CONTRIBUTING FACTORS WHICH COULD EXPLAIN THE SYMPTOMS. PATIENT WAS DESCRIBED AS A HEALTHY, FULLY COMPLIANT PERSON WITH GOOD MOTIVATION AND FOCUS ON POSTOP REHABILITATION. THE PATIENT HAS A NORMAL ACTIVITY LEVEL AND REGULAR CONTACT WITH PHYSIO. THE PATIENT IS NOW SCHEDULED TO HAVE AN ULTRASOUND GUIDED INJECTION AT THE OSSIFICATION SITE FOR DIAGNOSTIC PURPOSES. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    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. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT HAD A SONOGRAPHY-CONTROLLED INJECTION OF LOCAL ANESTHETIC AND CORTICOID AT THE SITE OF OSSIFICATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485545 G7 LONGEVITY NEUTRAL 36MM F PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65627100 00889024518759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other