BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ8 HI OFF

    MDR report key: 10350618 · Received July 31, 2020

    Report

    Report Number
    1818910-2020-17277
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    July 21, 2020
    Report Date
    July 21, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295060093
    PMA / PMN Number
    K001991
    Adverse Event
    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. 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.

    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 THAT PATIENT WAS ADMITTED TO PVH LATE LAST NIGHT FOR A PERIPROSTHETIC FRACTURE OF HIS PROXIMAL FEMUR. UPON OPENING THE JOINT IT WAS DETERMINED THIS PATIENT NEED A PROXIMAL FEMUR REPLACEMENT. THE PATIENT ALSO HAD A METAL ON METAL HIP THAT WAS PUT IN OVER 20 YEARS AGO. THE METAL LINER WAS REMOVED AND REPLACED WITH A POLY LINER. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815610 SUMMIT POR TAPER SZ8 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US 1570-11-150 XE7E81 10603295060093

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ARTICULEZE M HEAD 36MM +8.5| PINNACLE MTL INS NEUT36IDX58OD