BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM CORAIL

    MDR report key: 16642738 · Received March 30, 2023

    Report

    Report Number
    1818910-2023-06972
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    August 10, 2022
    Report Date
    March 30, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    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). THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. 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. 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

    ARTICLE ENTITLED ¿EFFECT OF NHA-COATED FEMORAL STEM PROSTHESIS COMBINED WITH PLATELET-RICH PLASMA IN HEMI HIP REPLACEMENT OF FEMORAL NECK FRACTURE IN THE ELDERLY¿ WRITTEN BY LU YANG, DABIN WU, TONGSHENG LIU, AND GUOZHENG FANG PUBLISHED IN HINDAWI ON AUGUST 10, 2022 WAS REVIEWED. THIS STUDY INVESTIGATED THE EFFICACY OF NANOHYDROXYAPATITE- (NHA-) COATED BIOLOGICAL PROSTHESIS COMBINED WITH PLATELETRICH PLASMA (PRP) IN HEMI HIP REPLACEMENT OF FEMORAL NECK FRACTURE (FNF) IN THE ELDERLY. 102 PATIENTS WERE INVOLVED IN THIS STUDY. 51 PATIENTS WERE IMPLANTED WITH BIPOLAR HIP WITH CORAIL STEM PLACEMENT FOR FNF. COMPETITOR BONE CEMENT WAS ALSO PLACED FOR THE FNF. ADVERSE EVENTS (NUMBER OF PATIENTS PER ADVERSE EVENT WASN¿T INCLUDED): PERIPROSTHETIC FEMORAL FRACTURE ¿ TREATMENT NOT INDICATED. DVT ¿ TREATMENT NOT INDICATED. POST-OP DISLOCATION OF HIP JOINT ¿ TREATMENT NOT INDICATED. PULMONARY INFECTION-TREATMENT NOT INDICATED. JOINT SINKING-TREATMENT NOT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172625 UNK HIP FEMORAL STEM CORAIL FEMORAL STEM LZO DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention