BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HIP FEMORAL STEM TRI-LOCK

    MDR report key: 18985150 · Received March 27, 2024

    Report

    Report Number
    1818910-2024-06761
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    January 1, 2023
    Report Date
    March 27, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT ==> THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A¿DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.¿ IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ARTICLE ENTITLED ¿CORRELATIONS BETWEEN THE FEMORAL NECK OSTEOTOMY ANGLE AND RADIOLOGIC AND CLINICAL OUTCOMES ANALYZED IN PATIENTS UNDERGOING TOTAL HIP REPLACEMENT WITH METAPHYSEAL FIXATION¿ WRITTEN BY Q.-X. WANG, Y.-J. SHANG, Y.-B. MA, Y.-S. LIU, Z.-M. LIU, Y.-T. HAN PUBLISHED IN EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES IN 2023 WAS REVIEWED. THE AIM OF THE STUDY IS TO EXPLORE WHETHER THE FEMORAL NECK OSTEOTOMY ANGLE (FNOA) HAS AN EFFECT ON HIP ANATOMICAL FUNCTIONAL RECONSTRUCTION AND CLINICAL OUTCOMES AFTER TOTAL HIP ARTHROPLASTY (THA). 296 HIPS (254 PATIENTS) WERE INCLUDED WITHIN THE STUDY. ALL UNDERWENT A PRIMARY THA WITH A TRILOCK STEM. THE MOST COMMON ACETABULAR CUP WAS A PINNACLE SIZE 52 CUP, WHICH IS COMMONLY PAIRED WITH CERAMIC HEAD. CLINICAL OUTCOMES: 10 CASES OF DISLOCATION. ONE OF THE PATIENTS IS CAPTURED WITHIN FIGURE 4. 68-YEAR-OLD FEMALE.¿ NO MENTION OF TREATMENT. 19 CASES OF THIGH PAIN ¿ NO MENTION OF TREATMENT. 1 CASE OF PERIPROSTHETIC FRACTURE ¿ NO MENTION OF TREATMENT. THERE WAS MENTION OF SOME TRILOCK STEMS SITTING PROUD OR IN VARUS/NON VARUS POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468850 UNK HIP FEMORAL STEM TRI-LOCK FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown