BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL CONSTRUCT SUMMIT

    MDR report key: 22041113 · Received May 17, 2025

    Report

    Report Number
    1818910-2025-08063
    Event Type
    Injury
    Date Received
    May 17, 2025
    Date of Event
    March 17, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H3, H6: 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. H3, H6: THE DEVICE LOT IS UNKNOWN; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MOSHER ZA, STRAIT AV, OLSON NR, WOLFE JA, HO PH, HOPPER RH JR, HAMILTON WG. VANCOUVER B FRACTURES AFTER USING CEMENTLESS FEMORAL FIXATION: A SINGLE CENTER EXPERIENCE. J ARTHROPLASTY. 2025 MAR 17: S0883-5403(25)00240-2. DOI: 10.1016/J.ARTH.2025.03.024. EPUB AHEAD OF PRINT. PMID: 40107572. OBJECTIVE/METHODS/STUDY DATA: THE OBJECTIVES OF THIS STUDY WERE TO EVALUATE AND COMPARE THE RATE OF VANCOUVER B FRACTURES AND SURVIVORSHIP AMONG PATIENTS AGED 18 TO 75 YEARS AT SURGERY WITH THOSE AGED > 75 YEARS AT SURGERY. THIS STUDY ALSO SOUGHT TO EXAMINE THE ASSOCIATION BETWEEN VANCOUVER B FRACTURE RATES AND FACTORS RELATED TO PATIENT DEMOGRAPHICS, SURGICAL TECHNIQUE, AND IMPLANT CHARACTERISTICS. BETWEEN JANUARY 1, 2009 AND DECEMBER 31, 2023, 12,400 THAS WERE PERFORMED USING UNCEMENTED STEMS WERE INCLUDED IN THE STUDY. THE MEAN AGE AT SURGERY WAS 64 YEARS, AND 57% OF THAS WERE PERFORMED AMONG WOMEN. THE MEAN FOLLOW-UP AMONG ALL THAS WAS 3.6 YEARS (RANGE, ZERO TO 14.8). TYPE OF STEM INCLUDE: ZIMMER M/L TAPER, STRYKER ACCOLADE, DEPUY TRI-LOCK, BIOMET TAPERLOC, DEPUY CORAIL, ZIMMER AVENIR, ZIMMER FITMORE, DEPUY SUMMIT, STRYKER SECUR-FIT, DEPUY ACTIS, DEPUY AML, AND DEPUY PRODIGY. A TOTAL OF 72 SUSTAINED POSTOPERATIVE PPFX, INCLUDING 33 VANCOUVER A, 34 VANCOUVER B, AND FIVE VANCOUVER C FRACTURES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES TRI-LOCK, CORAIL, SUMMIT, ACTIS FEMORAL STEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT SUMMIT (QTY 1): (N=1) PERIPROSTHETIC FRACTURE CLASSIFIED AS VANCOUVER B. TREATMENT: AMONG THOSE WHO HAD PERIPROSTHETIC FRACTURE CLASSIFIED AS VANCOUVER B, SIX PATIENTS WERE TREATED WITH OBSERVATION AND PROTECTED WEIGHT-BEARING (DEVICES UNKNOWN), WHILE THE REMAINING 28 UNDERWENT STEM REVISION (DEVICES UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142890 UNKNOWN HIP FEMORAL CONSTRUCT SUMMIT HIP FEMORAL STEM LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention