BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*STM STD,36NK,14X09X130

    MDR report key: 12373108 · Received August 26, 2021

    Report

    Report Number
    1818910-2021-18759
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 9, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295170853
    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). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. VISUAL EXAMINATION OF THE PROVIDED PHOTOGRAPHS 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 523191, WORK ORDER 7845768 WAS MANUFACTURED ON 12-FEB-2014. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. SCRAP: THERE WAS NO SCRAP ASSOCIATED WITH THIS LOT. REPROCESSING: THERE WAS NO MATERIAL REPROCESSING REPORTS (MRR) ASSOCIATED WITH THIS LOT. NON-CONFORMANCE: 1 NONCONFORMANCE IS ASSOCIATED WITH THIS LOT: NR-0003125 WAS OPENED IN RELATION TO 0-12" HEIGHT GAUGE CI058 THAT WAS FOUND TO BE OUT OF SPECIFICATION ON SCHEDULED CALIBRATION. THE ROOT CAUSE FOR THE GAUGE CAN BE WEAR OR DAMAGED TO THE GAUGE. THERE IS NO CORRELATION BETWEEN THIS NON-CONFORMANCE AND THE FAILURE MODE OF THE COMPLAINT. CERTIFICATE OF CONFORMANCE REVIEW FOR (B)(4), PRODUCT CODE 523191, WORK ORDER 7845768 MET SPECIFICATION.

    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

    IT WAS REPORTED THAT THE SROM STEM BROKEN AS SEEN IN PREOP XRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268619 S-ROM*STM STD,36NK,14X09X130 S-ROM HIP SYSTEM : HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US 52-3191 7845768 10603295170853

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DELTA CER HEAD 11/13 32MM +0| S-ROM*SLEEVE PRX ZT HA 14D-LRG| S-ROM*STM STD,36NK,14X09X130| DELTA CER HEAD 11/13 32MM +0| S-ROM*SLEEVE PRX ZT HA 14D-LRG| S-ROM*STM STD,36NK,14X09X130