BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM SROM

    MDR report key: 12220785 · Received July 23, 2021

    Report

    Report Number
    1818910-2021-15943
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    July 5, 2021
    Report Date
    July 5, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE) WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    (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 AS "AT SOME POINT IN THE PAST - DOS UNKNOWN, THE PATIENT UNDERWENT AN SROM ASR CONSTRUCT PERFORMED BY A SURGEON AT EITHER OCR OR PVH. THE PATIENT'S METAL ION COUNT IN HER BLOOD IS HIGH AND THERE WAS SUSPECTED METALLOSIS IN THE JOINT. ONCE OPEN, METALLOSIS WAS CONFIRMED IN THE JOINT. THERE WAS BLACK TISSUE SURROUNDING THE JOINT CAPSULE AND THE TRUNION OF THE SROM STEM WAS BLACK. THE ASR HEAD WAS REMOVED ALONG WITH THE SROM STEM. A NEW CONSTRUCT WAS UTILIZED TO COMBAT THE METALLOSIS." DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115825 UNK HIP FEMORAL STEM SROM FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 18X13 36 +12 SROM STEM.| ASR SPACER.| ASR UNI FEMORAL IMPL SIZE 49.| UNK HIP ACETABULAR CUP ASR.| 18X13 36 +12 SROM STEM| ASR SPACER| ASR UNI FEMORAL IMPL SIZE 49| UNK HIP ACETABULAR CUP ASR