BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL SLEEVE SROM

    MDR report key: 17170134 · Received June 21, 2023

    Report

    Report Number
    1818910-2023-12620
    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 (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

    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 3: A 48-YEAR-OLD FEMALE DIAGNOSED WITH LEFT CROWE IV DDH UNDERWENT THA USING A SHORTENING OSTEOTOMY WITH AN S-ROM PROSTHESIS. ONE YEAR AFTER THE OPERATION, SHE PRESENTED WITH PAIN AND LIMITED MOVEMENT IN THE LEFT LIMB. INTRAOPERATIVELY DURING REVISION, PATIENT¿S PROXIMAL FEMORAL BONE WAS WELL-INGROWN AND NOT LOOSE. THE DISTAL END WAS LOOSE AND THE SHORTENING OSTEOTOMY SITE WAS FOUND TO BE UNHEALED (NON-UNION). BONE GRAFTING WAS PLACED AROUND THE PROSTHESIS IN THE DISTAL CAVITY, AS WELL AS AT THE UNHEALED OSTEOTOMY SITE. THE PROXIMAL PORTION OF THE FEMUR WAS SECURED WITH SINGLE CORTICAL SCREW, WHEREAS THE DISTAL PORTION WAS TREATED USING TITANIUM PLATES, SCREWS, AND A CERCLAGE WIRE¿THE STEM AND SLEEVE WERE RETAINED. 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
    171944 UNK HIP FEMORAL SLEEVE SROM FEMORAL SLEEVE LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention