BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL SLEEVE SROM

    MDR report key: 15065109 · Received July 20, 2022

    Report

    Report Number
    1818910-2022-13505
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    December 17, 2019
    Report Date
    July 20, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    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. LITERATURE CITATION: KONG X, SUN Y, YANG M, ZHOU Y, CHEN J, CHAI W, WANG Y. TOTAL HIP ARTHROPLASTY WITH MODULAR STEM FOR CROWE I AND II DEVELOPMENTAL DYSPLASIA OF THE HIP. J ORTHOP SURG RES. 2019 NOV 13;14(1):362. DOI: 10.1186/S13018-019-1408-2. ERRATUM IN: J ORTHOP SURG RES. 2019 DEC 17;14(1):447. PMID: 31722721; PMCID: PMC6854780. OBJECTIVE/METHODS/STUDY DATA: AUTHORS RETROSPECTIVELY ANALYZED THE CLINICAL DATA OF 196 PATIENTS WITH UNILATERAL CROWE I AND II DDH FROM JANUARY 2015 TO JANUARY 2017. ONE HUNDRED PATIENTS WERE OPERATED BY AN EXPERIENCED SURGEON WITH THE MODULAR STEMS; THE REMAINING 96 PATIENT WAS OPERATED BY ANOTHER EQUIVALENT SURGEON WITH THE NON-MODULAR TAPERED STEMS. THE PREOPERATIVE BASIC INFORMATION, OPERATING TIME, INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS, POSTOPERATIVE LEG LENGTH DISCREPANCY (LLD) AND OFFSET, HARRIS HIP SCORE (HHS), AND FORGOTTEN JOINT SCORE (FJS) IN POSTOPERATIVE 2 YEARS WERE COLLECTED AND ANALYZED. TWO MANUFACTURER STEMS WERE SUBJECT OF STUDY: DEPUY SROM AND NON-DEPUY LINK LCU STEM. THIS COMPLAINT CAPTURES LISTED ADVERSE EVENTS FOR THE SROM GROUP. FIGURE 1 DEPICTS AN EXAMPLE OF 52 YEARS OLD MALE THAT WAS CHANGED TO S-ROM INTROPERATIVELY DUE TO POOR STABILITY OF THE NON-DEPUY TRIAL. NO ADVERSE EVENT NOTED IN CAPTION OR NARRATIVE DESCRIPTION FOR THIS PATIENT. FIGURES 2 AND 3 ARE RELATED TO NON-DEPUY PRODUCTS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 2 PERIPROSTHETIC FRACTURES OF PROXIMAL FEMUR DURING THE OPERATION - ALL PATIENTS TREATED WITH DELAY OF LOADING TIME AND HEALED EVENTUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899107 UNK HIP FEMORAL SLEEVE SROM FEMORAL SLEEVE LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention