BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM ST,36+6L NK,11X16X150

    MDR report key: 11670674 · Received April 15, 2021

    Report

    Report Number
    1818910-2021-07962
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 29, 2021
    Report Date
    March 29, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295178200
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. VISUAL EXAMINATION OF THE PROVIDED PHOTOGRAPH AND X-RAY IMAGES CONFIRMED THE REPORTED EVENT. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. 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. DEVICE HISTORY LOT : PRODUCT CODE 563517 WORK ORDER (B)(4) WENT THROUGH GEN LABEL STEP ON 01-APR-2015. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. NO SCRAP PARTS FOUND ASSOCIATED WITH LOT 8090932. NO NCS (NON-CONFORMANCES) FOUND ASSOCIATED WITH LOT 8090932. CERTIFICATE OF COMPLIANCE FOR LOT 7123084 WAS REVIEWED AS PART OF THIS DHR REVIEW. NO DEVIATIONS FOUND ASSOCIATED WITH LOT 7123084.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    HIP REVISION TO REMOVE BROKEN SROM AND PATIENT REPORT OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571790 SROM STM ST,36+6L NK,11X16X150 S-ROM HIP SYSTEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US 56-3517 8090932 10603295178200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention APEX HOLE ELIM POSITIVE STOP| DELTA CER HEAD 11/13 36MM +3| EA DELTA CER INSERT 36IDX52OD| PINN CAN BONE SCREW 6.5MMX15MM| PINN CAN BONE SCREW 6.5MMX25MM| PINN SECTOR W/GRIPTION 52MM| S-ROM*SLEEVE PRX ZTT, 16B-LRG