BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISYN HIP SYSTEM

    MDR report key: 8931669 · Received August 26, 2019

    Report

    Report Number
    2952369-2019-00004
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    April 28, 2016
    Report Date
    February 27, 2019
    Manufacturer
    CONSENSUS ORTHOPEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K003649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) WAS SERVED WITH A LEGAL COMPLAINT FILED BY THE PATIENT (B)(6). THE LEGAL COMPLAINT CITED PATIENT HAD A UNISYN HIP STEM, BODY AND NECK WITH FEMORAL HEAD MANUFACTURED BY CONSENSUS ORTHOPEDICS (HAYES MEDICAL AT THE TIME OF IMPLANTATION) IMPLANTED BY DR. (B)(6) AT (B)(6) ON (B)(6) 2008. LEGAL COMPLAINT FURTHER CITED THAT PATIENT HAS HAD ON-GOING COMPLICATIONS REQUIRING MULTIPLE REVISION SURGERIES. THE FOLLOWING INFORMATION IS PROVIDED FOR THE INDIVIDUAL PARTS REPORTED FOR CC19-009 UNISYN HIP SYSTEM REQUESTED: NECK, STANDARD, UNISYN, 30MM X 38MM, CATALOG # 3341-13038, LOT# 472333. FEMORAL HEAD, COCR, 36MM, SZ -5, NEU, +5, +10MM, CATALOG # 0007-1-3601, LOT# 170813. BODY, STANDARD, PLASMA, CATALOG # 3461-43034, LOT# 470616. STEM, FLUTED, STRAIGHT, UNISYN, 17MM X 160 CATALOG # 3422-11716, LOT# 471682A. LOCK NUT, UNISYN, 30MM, CATALOG# 3422-03000, LOT# 72009. (B)(4).

    Description of Event or Problem · 1

    (B)(6) WAS SERVED WITH A LEGAL COMPLAINT FILED BY THE PATIENT (B)(6). THE LEGAL COMPLAINT CITED PATIENT HAD A UNISYN HIP STEM, BODY AND NECK WITH FEMORAL HEAD MANUFACTURED BY CONSENSUS ORTHOPEDICS (HAYES MEDICAL AT THE TIME OF IMPLANTATION) IMPLANTED BY DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6) ON (B)(6) 2008. LEGAL COMPLAINT FURTHER CITED THAT PATIENT HAS HAD ON-GOING COMPLICATIONS REQUIRING MULTIPLE REVISION SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724855 UNISYN HIP SYSTEM UNISYN HIP SYSTEM LPH CONSENSUS ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R