BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BONE CEMENT

    MDR report key: 19096062 · Received April 12, 2024

    Report

    Report Number
    1818910-2024-08192
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    September 2, 2022
    Report Date
    April 12, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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. 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. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WAKAMA H, OKAMOTO Y, OKAYOSHI T, IKEDA K, MATSUYAMA J, OTSUKI S, NEO M. UNFAVORABLE CORTICAL HYPERTROPHY POTENTIALLY PREDISPOSES TO PERIPROSTHETIC "AXE SPLITTER" FRACTURE IN A COLLARLESS POLISHED CURVED TRIPLE-TAPERED CEMENTED STEM: THE TIME-DEPENDENT RADIOGRAPHIC CHANGE IN FIVE SC-STEM CASES. J ORTHOP SCI. 2024 JAN;29(1):439-444. DOI: 10.1016/J.JOS.2022.09.004. EPUB 2022 SEP 29. PMID: 36182639. OBJECTIVE AND METHODS: THE PERIPROSTHETIC FRACTURE OF CEMENTED POLISHED TAPERED STEMS IS SOMETIMES CALLED A "UNIQUE" OR "AXE SPLITTER" FRACTURE. AUTHORS SOUGHT TO UNDERSTAND WHETHER THERE WERE ANY RADIOGRAPHIC INTERPRETATIONS ASSOCIATED WITH THIS FRACTURE PATTERN. THEY REPORTED ON FIVE CASES OUT OF 559 TOTAL HIP ARTHROPLASTIES (THA) USING A COLLARLESS POLISHED CURVED TRIPLE-TAPERED CEMENTED STEM FOR THE TREATMENT OF OSTEOARTHRITIS BETWEEN JANUARY 2010 AND DECEMBER 2018, WITH PFFS WITH AN ¿AXE SPLITTER FRACTURE¿ ASSOCIATED WITH LOW ENERGY TRAUMA. CEMENTED COMPETITOR ALL-POLYETHYLENE CUPS WERE PAIRED WITH COMPETITOR FEMORAL STEMS AND HEADS IN ALL INSTANCES, CEMENTED USING DEPUY ENDURANCE BONE CEMENT IN ALL THA CASES. AUTHORS INVESTIGATED THE PATIENT CHARACTERISTICS AND SERIAL RADIOGRAPHS OF FIVE FRACTURE CASES AND EVALUATED THE TIME-DEPENDENT SPECIFIC RADIOGRAPHICAL CHANGES AROUND THE STEM BETWEEN PRE-ARTHROPLASTY AND FRACTURE ONSET. RESULTS: FRACTURES DEVELOPED AT 3.5-6.4 YEARS AFTER SURGERY WITH LOW-GRADE INJURY OR WITH NO PARTICULAR PRECIPITATING CAUSE. FEMORAL CORTICAL HYPERTROPHY AT THE DISTAL MEDIAL SIDE AROUND THE STEM WAS OBSERVED IN ALL CASES BEFORE THE DEVELOPMENT OF FRACTURES, AT 2-6 YEARS AFTER PRIMARY SURGERY. THE DURATION BETWEEN CORTICAL HYPERTROPHY APPEARANCE TO THE DEVELOPMENT OF FRACTURE WAS 0.4-3.1 YEARS. IN ADDITION TO THE FEMORAL PERIPROSTHETIC FRACTURES, ALL FIVE PATIENTS EXPERIENCED BETWEEN 1.0 ¿ 7.0MM OF STEM SUBSIDENCE. CASES 3, 4, AND 5 ALSO EXPERIENCED FEMORAL STEM LOOSENING (SPECIFIC INTERFACE WAS NOT SPECIFIED)¿CASES 1 AND 2 DID NOT. CONCLUSIONS: THE APPEARANCE OF THIS ZONE-SPECIFIC CORTICAL HYPERTROPHY MIGHT PLAY A KEY ROLE IN THE OCCURRENCE OF PERIPROSTHETIC FRACTURES. FURTHER STUDIES WITH LARGER SAMPLE SIZES SHOULD TO BE CONDUCTED TO DETERMINE IF THIS IS A FACTOR IN PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769874 UNKNOWN BONE CEMENT BONE CEMENT LOD DEPUY IRELAND - 3015516266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention