BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 17038877 · Received June 1, 2023

    Report

    Report Number
    1818910-2023-11288
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    February 14, 2023
    Report Date
    June 1, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION 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. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: XIN P, NI M, JI Q, YANG X, GENG L, WANG Y, ZHANG G. USING MESH IN CAPSULE ANATOMICAL RECONSTRUCTION TO ENHANCE THE STABILITY OF HIGH-DISLOCATION-RISK HIP ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL. J ORTHOP SURG RES. 2023 FEB 14;18(1):102. DOI: 10.1186/S13018-023-03575-1. PMID: (B)(6); PMCID: (B)(6); OBJECTIVE AND METHODS: THIS STUDY AIMED TO COMPARE THE OUTCOMES OF COMPETITOR MESH RECONSTRUCTION VERSUS CONVENTIONAL CAPSULAR REPAIR IN MAINTAINING CAPSULAR INTEGRITY AND PREVENTING DISLOCATION AFTER 106 THAS PERFORMED BETWEEN SEPTEMBER 2020 AND OCTOBER 2021 UTILIZING DEPUY PRODUCTS. THE PRODUCTS USED IN EACH THA VARIED DEPENDING ON PATIENT ANATOMY: PINNACLE CUPS, TRILOCK STEM, CORAIL STEM, CORAIL REVISION STEM, ACETABULAR SCREWS, AND UNKNOWN HEADS AND LINERS ASSUMED TO BE DEPUY PRODUCTS. ALL PATIENTS RECEIVED PREOPERATIVE TEMPLATING AND SOFT TISSUE CLOSURE FOR ALL PATIENTS WAS DONE WITH ABSORBABLE ETHICON SUTURES. THIS COMPLAINT WILL CAPTURE THE DEPUY RESULTS FOR 3 PATIENTS WITH POSTOPERATIVE DISLOCATIONS AS WELL AS THE RESULTS NOT ASSOCIATED WITH SPECIFIC PATIENTS. THE RESULTS RELATED TO THE COMPETITOR MESH WILL BE EXCLUDED. THE RESULTS DO NOT SPECIFY THE THA CONSTRUCTS AND AS SUCH, THE DEVICES WILL BE CAPTURED AS UNKNOWN PRODUCTS. RESULTS: A TOTAL OF 18 PATIENTS HAD A FAILED CAPSULAR REPAIR; ONE IN THE MESH GROUP AND 18 IN THE STANDARD GROUP. NO TREATMENT WAS SPECIFIED. PATIENT 3: 71-YEAR-OLD FEMALE PATIENT WITH LEFT HIP THA TO TREAT A FEMORAL FRACTURE AND FAILED CAPSULAR REPAIR EXPERIENCED A POSTOPERATIVE DISLOCATION 11 MONTHS AFTER PRIMARY SECONDARY TO PROLONGED SQUATTING. PATIENT WAS TREATED WITH CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681498 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention