BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR POLY/METAL HEMI

    MDR report key: 14775195 · Received June 22, 2022

    Report

    Report Number
    1818910-2022-11457
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    January 1, 2017
    Report Date
    June 22, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    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). 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIANG HAILIANG, GUO KAIJIN, WANG XIANG, LI JIE. COMPARISON OF BIOTYPE AND CEMENTED PROSTHESIS HEMIARTHROPLASTY IN THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FRACTURES IN THE ELDERLY [J]. CHINESE JOURNAL OF TISSUE ENGINEERING, STUDY, 2017, 21 (23): 3622-3627. DOI:10.3969/J.ISSN .2095-4344.2017.23.003 ORCID: 0000-0002-6583-7878 (JIANGHAILIANG). OBJECTIVE AND METHODS: THIS PAPER TO COMPARE THE CLINICAL EFFICACY OF CEMENTED AND UNCEMENTED HEMIARTHROPLASTY FOR UNSTABLE INTERTROCHANTERIC FRACTURES IN 93 ELDERLY PATIENTS IMPLANTED BETWEEN MAY 2009 AND MAY 2014. THE AUTHORS UTILIZED AN UNSPECIFIED JOHNSON AND JOHNSON BIPOLAR FEMORAL HEAD AND STEM. MANUFACTURER OF THE CEMENT IS UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: BIPOLAR FEMORAL HEAD AND FEMORAL STEM ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: 10 RADIOGRAPHICALLY IDENTIFIED STEM MIGRATIONS LESS THAN 3 MM. NO TREATMENT PROVIDED. 2 DISLOCATIONS TREATED WITH SPICA CASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546454 UNKNOWN HIP ACETABULAR POLY/METAL HEMI HIP ACETABULAR POLY/METAL HEMI LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention