BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*STM LG 36+8L 18X13X215N

    MDR report key: 13930428 · Received March 28, 2022

    Report

    Report Number
    1818910-2022-05657
    Event Type
    Injury
    Date Received
    March 28, 2022
    Date of Event
    June 18, 2015
    Report Date
    March 28, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LWJ
    UDI-DI
    10603295177821
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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 REPORT, A FOLLOW-UP REPORT 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. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (B)(4) AND LOT 2783353, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    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.

    Description of Event or Problem · 0

    PATIENT HAS HAD SEVERAL REVISIONS IN THE PAST 20 YEARS. MOST RECENT REVISION COMPLETED DUE TO INSTABILITY. IT WAS DISCOVERED DURING SURGERY THAT THE SROM FEMAL STEM FRACTURED. A PIECE OF THE STEM WAS LEFT BEHIND IN THE FEMORAL CANAL. SURGEON EXCHANGED THE FEMORAL HEAD AND REMOVED THE ESCA ALUMINA CERAMIC ACETABULAR BEARING THAT WAS ORIGINAL FROM THE PRIMARY SURGERY. A CONSTRAINED LINER WAS IMPLANTED. PRIMARY SURGERY - RIGHT HIP; APPROXIMATELY 20 YEARS AGO - DETAILS UNKNOWN. ESCA HIP IMPLANTED (NO DEPUY PRODUCTS INVOLVED). REVISION 1: *REVISION OF ESCA PRODUCTS* (B)(6) 2009, (B)(6) HOSPITAL, DR. (B)(6). USAGE: 563118N, SROM*STM LG 36+8L 18X13X215N, 2783353; 550727, S-ROM*SLVE ZTTOVSZ 20F-SML18ID, 2785308; 528323, S-ROM*HEAD FEMRL ALUMINA 32+0, 2224752. REVISION 2 ((B)(4)- CURRENT PC). *REVISION OF DEPUY PRODUCTS - ESCA PRODUCTS LEFT IN SITU* (B)(6) 2015, (B)(6) HOSPITAL, DR. (B)(6) . USAGE: 523420, S-ROM STM ST 36+8L NK 20X15X16, 7774624; 550738, S-ROM SLEEVE ZTTOVSZ 22F-LRG20ID, 3200641; 136532210, DELTA CER HEAD 11/13 32MM +0, 8042154. REVISION RIGHT HIP (B)(4). *REVISION OF BOTH ESCA AND DEPUY PRODUCTS* (B)(6) 2022, (B)(6) HOSPITAL, DR. (B)(6). USAGE: 522028, S-ROM HEAD FEMORAL COCR 28+0, 9308200.

    Description of Event or Problem · 0

    PLEASE CONFIRM IF THE SROM STEM WAS THE ONLY FRACTURED COMPONENT IN THIS EVENT. AS PER THE EVENT DESCRIPTION; THE SROM STEM WAS THE ONLY FRACTURED COMPONENT IN THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329562 SROM*STM LG 36+8L 18X13X215N S-ROM HIP SYSTEM : HIP FEMORAL STEM LWJ DEPUY ORTHOPAEDICS INC US 56-3118N 2783353 10603295177821

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention S-ROM*SLVE ZTTOVSZ 20F-SML18ID| UNK HIP FEMORAL HEAD METAL SROM