BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM SUMMIT

    MDR report key: 15299306 · Received August 25, 2022

    Report

    Report Number
    1818910-2022-16719
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    March 3, 2022
    Report Date
    August 25, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ALPAUGH K, CHIU YF, ZLOTNICKI JP, BENDICH I, VALLE AGD, BOSTROM MPG, GAUSDEN EB. FEMORAL COMPONENT UNDERSIZING AND ALIGNMENT ARE RISK FACTORS FOR EARLY PERIPROSTHETIC FEMUR FRACTURE. J ARTHROPLASTY. 2022 JUL;37(7S):S604-S610. DOI: 10.1016/J.ARTH.2022.03.015. EPUB 2022 MAR 11. PMID: 35283234. OBJECTIVE AND METHODS: AUTHORS CONDUCTED A RETROSPECTIVE ANALYSIS FROM 16065 PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTIES (THA), IDENTIFYING 66 CASES OF EARLY (<90 DAYS POST-OP FROM INDEX THA) PERIPROSTHETIC FEMUR FRACTURE (PFF). 60 OF THESE WERE MATCHED UP WITH 120 CONTROLS OF LIKE AGE, GENDER, BMI, SURGICAL APPROACH, AND SAME MANUFACTURER/MODEL/OFFSET FOR STEM IMPLANT. THEY SOUGHT TO UNDERSTAND THE EFFECTS OF FEMORAL COMPONENT SIZE AND ALIGNMENT AND THEIR ASSOCIATION WITH THE RISKS OF EARLY PFF. RADIOGRAPHIC ASSESSMENTS WERE PREFORMED OF PREOPERATIVE BONE MORPHOLOGY AND POSTOPERATIVE FEMORAL COMPONENT ORIENTATION¿INCLUDING STEM ALIGNMENT, METAPHYSEAL FILL, AND IMPLANT CONGRUENCE WITH MEDIAL CORTICAL BONE. OF THE SIXTY HIPS IN THE PFF STUDY SUBJECTS, THERE WERE 3 DEPUY SUMMIT STEMS, 1 DEPUY CORAIL STEM, 1 DEPUY TRILOCK STEM¿THE REMAINDER WERE ALL FROM 6 OTHER MANUFACTURERS. THE SIX PATIENTS OF THE TOTAL 66 WHO WERE EXCLUDED, WERE ALL COMPETITOR STEMS, AND THERE WERE NO CONTROL PATIENTS THAT ADEQUATELY MATCHED THEIR PROFILES. ACETABULAR COMPONENTS WERE NOT IDENTIFIED IN ANY CASE. RESULTS: THE AUTHORS¿ MULTIVARIATE ANALYSIS FOUND THAT LARGER LATERAL METAPHYSEAL CANAL TO BONE RATIOS, VALGUS COMPONENT ALIGNMENT, AND IMPLANT INCONGRUITY WITH MEDIAL CORTICAL BONE POSED THE GREATEST RADIOGRAPHIC RISK FOR EARLY PFF FOLLOWING CEMENTLESS THA. AUTHORS DID NOT BREAK OUT THE RESULTS BY CASE NUMBER OR BY AGE/GENDER DEMOGRAPHICS. SPECIFIC IMPLANT SIZE OR ALIGNMENT INCONGRUITIES WERE NOT PROVIDED FOR EACH MANUFACTURER. ALL STEMS INVOLVED WERE COLLARLESS. 3 : SUMMIT PERIPROSTHETIC FEMUR FRACTURES, 1 : CORAIL PERIPROSTHETIC FEMUR FRACTURE, 1 : TRILOCK PERIPROSTHETIC FEMUR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478485 UNK HIP FEMORAL STEM SUMMIT FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNK HIP FEMORAL STEM CORAIL| UNK HIP FEMORAL STEM TRI-LOCK