BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM SROM

    MDR report key: 17170049 · Received June 21, 2023

    Report

    Report Number
    1818910-2023-12615
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    December 21, 2022
    Report Date
    June 21, 2023
    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). D4-THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. H6 COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (B)(4) 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MA Y, MA X, CHENG S, LV S, QI X. IMPLANT LOOSENING FOLLOWING THA WITH S-ROM PROSTHESIS AND SUBTROCHANTERIC OSTEOTOMY: THREE CASE REPORTS. FRONT SURG. 2023 JAN 30;9:1090067. DOI: 10.3389/FSURG.2022.1090067. PMID: 36793511; PMCID: PMC9922855. OBJECTIVE/METHODS/RESULTS: AUTHORS REPORT THREE CASES WITH CROWE IV DDH WHO DEVELOPED PROSTHESIS LOOSENING FOLLOWING THA WITH AN S-ROM PROSTHESIS AND SUBTROCHANTERIC OSTEOTOMY. AUTHORS ADDRESS THE MANAGEMENT OF THESE PATIENTS AND PROSTHESIS LOOSENING AND THE LIKELY UNDERLYING CAUSES. CASE 2: A 59-YEAR-OLD MALE, DIAGNOSED WITH CROWE TYPE IV DDH AFFECTING THE LEFT HIP WAS TREATED SUCCESSFULLY WITH SHORTENING SUBTROCHANTERIC OSTEOTOMY AND DEPUY S-ROM FEMORAL STEM THA. 5 YEARS POST-OP, PATIENT FELL, RECEIVED NO SIGNIFICANT TREATMENT, AND WAS EVENTUALLY (AFTER 6 MONTHS OF PROGRESSIVE DISCOMFORT) DIAGNOSED WITH ASEPTIC LOOSENING OF THE HIP PROSTHESIS. SURGICALLY, IT WAS DISCOVERED THAT THE PROXIMAL SECTION OF THE S-ROM PROSTHESIS FUSED ENTIRELY WITH THE BONE. THE DISTAL FEMUR, IN CONTRAST, WAS LOOSE, DUE TO THE BONE AT THE ORIGINAL OSTEOTOMY SITE NOT HAVING HEALED (NON-UNION); THEREFORE, BONE GRAFTING WAS PRE-FORMED AT THE DISTAL STEM MEDULLARY CAVITY AND AT THE NON-HEALED OSTEOTOMY SITE. TITANIUM PLATES, SCREWS AND CERCLAGE FIXATION WERE UTILIZED TO REDUCE AND TREAT THE FRACTURE NON-UNION. AFTER SIX MONTHS OF FOLLOW-UP, PATIENT REPORTED NEARLY NO DISCOMFORT, ABLE TO WALK UP AND DOWN STAIRS UNASSISTED, AND THEIR HARRIS HIP SURVEY SCORE AFTER REVISION EXCEEDED 85. THE AUTHORS DID NOT IDENTIFY THE MANUFACTURER(S) OF THE PATIENT¿S ACETABULAR COMPONENTS. NO SPECIFIC PRODUCT DETAILS WERE PROVIDED FOR ANY OF THE DEVICES USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190825 UNK HIP FEMORAL STEM SROM FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention