BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM SROM

    MDR report key: 15055802 · Received July 19, 2022

    Report

    Report Number
    1818910-2022-13440
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    November 30, 2020
    Report Date
    July 19, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. LITERATURE CITATION: KOBAYASHI K, KIDERA K, ITOSE M, MOTOKAWA T, CHIBA K, OSAKI M. HIGHER INCIDENCE OF ASEPTIC LOOSENING CAUSED BY A LOWER CANAL FILLING RATIO WITH A MODIFIED MODULAR STEM IN TOTAL HIP ARTHROPLASTY. J ORTHOP SURG RES. 2020 NOV 30;15(1):568. DOI: 10.1186/S13018-020-02101-X. PMID: 33256767; PMCID: PMC7706283. OBJECTIVE/METHODS/STUDY DATA: A TOTAL OF 144 PATIENTS (154 HIPS) WHO UNDERWENT TOTAL HIP ARTHROPLASTY USING THE MODULAR PROSTHESIS WERE RETROSPECTIVELY INVESTIGATED. FOR THE COHORT STUDY, 97 PATIENTS (104 HIPS) WERE INCLUDED. THE FEMORAL COMPONENT SURVIVAL RATE AND SLEEVE FIXATION WERE ASSESSED AT A MINIMUM FOLLOW-UP OF 5 YEARS. 97 PATIENTS (MALE, N = 20; FEMALE, N= 77; MEAN AGE AT SURGERY, 62 (36¿84) YEARS; FOLLOW-UP, 8 (5¿10) YEARS; HIPS, N = 104) WERE ASSESSED (FIG. 1). THE UNDERLYING DIAGNOSES WERE OSTEOARTHRITIS (N = 7; PRIMARY N = 89; SECONDARY), RHEUMATOID ARTHRITIS (N = 1), TRAUMA+B21(N = 2), RAPIDLY DESTRUCTIVE COXARTHROPATHY (N = 3), AND OSTEONECROSIS (N = 2). PATIENTS WERE DIVIDED INTO 2 GROUPS, INCLUDING STABLE AND UNSTABLE FIXATION GROUPS, BY SLEEVE FIXATION. CLINICAL AND RADIOGRAPHIC OUTCOMES WERE COMPARED. ALL PATIENTS RECEIVED DEPUY SROM STEM. THE ACETABULAR COMPONENT WAS EITHER A DEPUY PINNACLE-A CUP (QTY 96) OR A NON-DEPUY CEMENTED CUP (STD-CP BY JMM - QTY 8). ALL BEARING SURFACES WERE COBALT-CHROMIUM ON HIGHLY CROSS-LINKED POLYETHYLENE. SLEEVE FIXATION WAS CLASSIFIED AS STABLE (NO RADIOLUCENT LINES OR SLIGHT RADIOLUCENT LINES AROUND THE SLEEVE) OR UNSTABLE (EXTENSIVE RADIOLUCENT LINE AROUND THE SLEEVE WITH PROGRESSIVE SUBSIDENCE OR MIGRATION). ALTHOUGH THE ARTICLE DOES NOT SPECIFY WHICH MANUFACTURER DEVICE OF ACETABULAR SIDE ARE ASSOCIATED WITH THE ADVERSE EVENTS, THE MAJORITY OF PATIENTS WERE IMPLANTED WITH DEPUY PRODUCTS. FOR THIS REASON, QUANTITIES CANNOT BE ACCURATELY DETERMINED UNTIL ADDITIONAL INFORMATION IS RECEIVED FROM PERFORMING FOLLOW UP ACTIVITY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 5 LOOSE STEMS TREATED WITH REVISION, QTY 1 DISLOCATION TREATED WITH REVISION, QTY 8 INTRAOPERATIVE FRACTURES (IMPACTION INSTRUMENTS ARE NOT IDENTIFIED WITHIN THE ARTICLE), QTY 1 POST-OPERATIVE PERIPROSTHETIC FRACTURE (NO TREATMENT SPECIFIED). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS SPECIFICALLY FOR THE SROM SLEEVE: QTY 16 HIPS CATEGORIZED WITH UNSTABLE FIXATION (EXTENSIVE RADIOLUCENT LINES WITH PROGRESSIVE SUBSIDENCE OR MIGRATION) RADIOGRAPHIC FINDINGS ONLY NO TREATMENT PROVIDED - EXAMPLE WITHOUT PATIENT IDENTIFIERS ILLUSTRATED IN FIGURE 2 (D).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262665 UNK HIP FEMORAL STEM SROM FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention