BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ3 HI OFF

    MDR report key: 10278109 · Received July 15, 2020

    Report

    Report Number
    1818910-2020-15937
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    July 2, 2020
    Report Date
    July 2, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295060048
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THE PATIENT HAD HER HIP REPLACED ON (B)(6) 2020 BY SURGEON. I WAS NOTIFIED THE AM OF THE SURGERY THAT THE PATIENT HAD AN OFFICE VISIT WITH DR. K. UPON HER EXAMINATION, IT WAS DETERMINED THAT HER HIP WAS INFECTED AND AN I&D AS WAS TO BE DONE. DURING THE PROCEDURE SURGEON EXPLANTED ALL OF THE COMPONENTS SHE HAD IMPLANTED, DID A THOROUGH DEBRIDEMENT AND IMPLANTED A NEW SUMMIT PINNACLE CONSTRUCT. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743308 SUMMIT POR TAPER SZ3 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US 1570-11-090 J56A64 10603295060048

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ALTRX +4 NEUT 32IDX50OD| DELTA CER HEAD 12/14 32MM +5| PINNACLE SECTOR II CUP 50MM| SUMMIT POR TAPER SZ3 HI OFF