BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 15265458 · Received August 22, 2022

    Report

    Report Number
    1818910-2022-16248
    Event Type
    Injury
    Date Received
    August 22, 2022
    Date of Event
    April 20, 2021
    Report Date
    August 22, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    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

    ARTICLE ENTITLED ¿IS SURGICAL APPROACH FOR PRIMARY TOTAL HIP ARTHROPLASTY ASSOCIATED WITH TIMING, INCIDENCE, AND CHARACTERISTICS OF PERIPROSTHETIC FEMUR FRACTURES? " WRITTEN BY KATHERINE A. LYGRISSE, MD, GAUKHMAN D. GAUKHMAN, MD, MS, GREG TEO, MD, RAN SCHWARZKOPF, MD, MSC, WILLIAM J. LONG, MD, FRCSC, VINAY K. AGGARWAL, MD, PUBLISHED BY THE JOURNAL OF ARTHROPLASTY ON 04/20/2021 WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFECT OF SURGICAL APPROACH DURING PRIMARY THA ON EARLY PFF WITH RESPECT TO FRACTURE TIMING, INCIDENCE, RADIOGRAPHIC PARAMETERS, AND SURGERY-RELATED FACTORS. METHODS: A RETROSPECTIVE REVIEW OF ALL PATIENTS WITH PFF (PERIPROSTHETIC FEMUR FRACTURE) DURING OR AFTER PRIMARY THA FROM 2011 TO 2019 WAS CONDUCTED AT A SINGLE, URBAN ACADEMIC INSTITUTION. OF THE STUDY COHORT OF 11,915 PATIENTS, 79 PATIENTS WITH PFF WERE IDENTIFIED (0.66%). DIRECT ANTERIOR (DA), POSTERIOR ANTERIOR (PA), AND LATERALLY BASED (LA) COHORTS WERE FORMED BASED ON THE SURGICAL APPROACH. PA AND LA GROUPS WERE COMBINED TO FORM A NONANTERIOR (NA) COHORT. RADIOGRAPHIC PARAMETERS, SURGICAL FACTORS, AND FRACTURE MECHANISM WERE ANALYZED. PATIENTS WHO UNDERWENT DA THA HAVE SIGNIFICANTLY SHORTER TIME TO PFF AND WERE MORE OFTEN IDENTIFIED POSTOPERATIVELY WITH AN ATRAUMATIC MECHANISM THAN PATIENTS WHO UNDERWENT NA APPROACHES. THE KNOWN DIFFICULTY IN FEMORAL EXPOSURE AND STEM PLACEMENT WITH THE DA APPROACH MAY PLAY A ROLE IN CONTRIBUTING TO A HIGHER RATE OF INTRAOPERATIVE OR EARLY POSTOPERATIVE PFF. OF 11,915 THA PERFORMED AT OUR INSTITUTION, 79 PATIENTS UNDERWENT PRIMARY THA WITH SUBSEQUENT PERIPROSTHETIC FRACTURE FOR AN OVERALL INCIDENCE OF 0.66%. A VARIETY OF STEM TYPES AND MANUFACTURERS WERE USED IN THIS STUDY, INCLUDING SOME DEPUY STEMS. COMPLICATIONS NOTED WERE: 10 INTRAOPERATIVE FRACTURES, WITH VARIOUS TREATMENTS DURING SURGERY, INCLUDING ORIF, LARGER STEM. 59 REVISION FOR PFF WERE NOTED, AND 7 PATIENTS REQUIRED MULTIPLE REVISIONS. SOME OF THE COMPLICATIONS/REASONS FOR REREVISION INCLUDED: IRRIGATION AND DEBRIDEMENT WITH LINER EXCHANGE, REMOVAL OF HIP PROSTHESIS AND ANTIBIOTIC SPACER PLACEMENT, DISLOCATION, WOUND INFECTION. THE ENTIRE STUDY WAS FOR PERIPROSTHETIC FEMUR FRACTURES AND SOME OF THE STEMS WERE DEPUY STEMS, SO IT IS REASONABLE TO ASSUME THAT DEPUY STEMS WERE INVOLVED IN AT LEAST ONE OF THE FRACTURES AND CAN NOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310153 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWY DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention