BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/ GRIPTION 54MM

    MDR report key: 3020659 · Received March 18, 2013

    Report

    Report Number
    MW5029432
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    February 12, 2009
    Report Date
    March 18, 2013
    Manufacturer
    DEPUY
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    RIGHT TOTAL HIP ARTHROPLASTY: (B)(6) 2009 - (B)(6) 2009. ACUTE BLOOD LOSS ANEMIA, PRESCRIPTION OF LOVENO FOR PREVENTION OF DEEP VENOUS THROMBOSIS. LEFT PERONEUS LONGUS TENDON RUPTURE REQUIRING SURGERY: (B)(6) 2009. SURGERY TO REPAIR LEFT PERONEUS LONGUS TENDON RUPTURE: (B)(6) 2010. MECHANICAL LOOSENING: (B)(6) 2010. FLUID COLLECTION IN OR AROUND THE JOINT: (B)(6) 2011 TO (B)(6) 2011. METALLOSIS: (B)(6) 2011. EXPLANT AND REVISION SURGERY WITH PINNACLE HIP IMPLANT: (B)(6) 2011. CONTINUED PAIN: (B)(6) 2011. DISLOCATION OF IMPLANT: (B)(6) 2011. EXPLANT AND REVISION SURGERY WITH UNK DEVICE: (B)(6) 2011. DISLOCATION OF IMPLANT: (B)(6) 2011. DISLOCATION OF IMPLANT: (B)(6) 2011. EXPLANT AND REVISION SURGERY: (B)(6) 2012. ON (B)(6) 2011; PHYSICAL THERAPY. ON (B)(6) 2011; EMERGENCY ROOM VISIT DUE TO DISLOCATION. ON (B)(6) 2010 TO PRESENT; PAIN MEDICATION. ON (B)(6) 2011; CONSULTS WITH OTHER PHYSICIANS FOR PAIN AND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112310 PINN SECTOR W/ GRIPTION 54MM HIP IMPLANT SECTOR LPH DEPUY 1217-32-054 CC5FB1000
    112311 ARTICUL/EZE MOM FEMORAL HEAD 36 12/14+8.5 HIP IMPLANT FEMORAL HEAD LZO DEPUY 1365-53-000 2753088
    112432 PINNACLE ACETABULAR CUP SYSTEM HIP IMPLANT CUP LPH DEPUY
    112433 PINNACLE HIP IMPLANT WITH MOM LINER HIP IMPLANT LINER LPH DEPUY
    112434 PINNACLE METAL INSERT 36X54 HIP IMPLNAT METAL INSERT LPH DEPUY 1216-67-354 3789755
    112435 DEPUY TRI-LOCK BPS W/ GRIPTION FEMORAL STEM SZ 4 OFFSET HI HIP IMPLANT FEMORAL STEM LPH DEPUY 1012-14-040 DA5DX1000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R| S