BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM TOTAL HIP SYSTEM ZTT OVERSIZE PROXIMAL SLEEVE

    MDR report key: 2935593 · Received January 25, 2013

    Report

    Report Number
    MW5028777
    Event Type
    Injury
    Date Received
    January 25, 2013
    Report Date
    January 23, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A BILATERAL TOTAL HIP REPLACEMENT ON (B)(6) 2004. I RECEIVED THE DEPUY TOTAL HIP SYSTEM PINNACLE 100 ACETABULAR CUP SZ MM56 ON THE RIGHT HIP AND A SZ MM58 ON THE LEFT HIP. PRIOR TO SURGERY, I HAD PAIN IN MY HIPS DUE TO DEGENERATIVE JOINT DISEASE. ON (B)(6) 2011 I HAD A BLOOD TEST AND I WAS DIAGNOSED WITH HIGH LEVELS OF CHROMIUM AND COBALT IN MY BLOOD. I HAD TO HAVE A BILATERAL TOTAL HIP REVISION ON (B)(6) 2011 REQUIRING ADD'L HOSPITALIZATION. PREOPERATIVE DIAGNOSIS: BILATERAL METALLOSIS OF TOTAL HIP REPLACEMENTS. POSTOPERATIVE DIAGNOSIS: BILATERAL METALLOSIS OF TOTAL HIP REPLACEMENTS, AND OSTEOLYSIS OF THE PROXIMAL FEMUR. PROCEDURE PERFORMED: BILATERAL TOTAL HIP REVISIONS. ANESTHESIA: SPINAL AND GENERAL. ESTIMATED BLOOD LOSS: RIGHT: 200 ML. LEFT: 200 ML. PROCEDURE: THE PATIENT HAD BILATERAL DEPUY MODULAR METAL-ON-METAL TOTAL HIP REPLACEMENTS (B)(6) 2004. HE HAD EVIDENCE OF OSTEOLYSIS OF THE PROXIMAL FEMUR, AND HIP ASPIRATION REVEALED MASSIVE EFFUSION AND FLUID COMPATIBLE WITH METALLOSIS. HE WAS CLEARED FOR SURGERY, BROUGHT TO THE OPERATING ROOM, AND TRANSFERRED TO THE OPERATING TABLE IN THE SUPINE POSITION. SATISFACTORY SPINAL, THEN GENERAL ANESTHETIC WAS DONE. DATES OF USE: (B)(6) 2004 - (B)(6) 2011. REASON FOR USE: BILATERAL HIP DEGENERATIVE JOINT DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36225 S-ROM TOTAL HIP SYSTEM ZTT OVERSIZE PROXIMAL SLEEVE TOTAL HIP SYSTEM PROXIMAL SLEEVE JDI DEPUY ORTHOPAEDICS, INC. 1228381
    36226 ULTRAMET M+L INS NEUT 36MM 5-8 DM INSERT KWA DEPUY ORTHOPAEDICS, INC. 1215270
    36227 S-ROM TOTAL HIP SYSTEM ZTT OVERSIZE PROXIMAL TOTAL HIP SYSTEM PROXIMAL SLEEVE JDI DEPUY ORTHOPAEDICS, INC. 1034372
    36228 S-ROM TOTAL HIP SYSTEM FEMORAL STEM STANDARD FEMORAL STEM JDI DEPUY ORTHOPAEDICS, INC. 1197962
    36279 DEPUY PINNACLE ACETABULAR CUP SYSTEM 58 MM METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC. YR7EA1000
    36288 DEPUY PINNACLE ACETABULAR CUP SYSTEM 56MM METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC. YW3DD1000
    36289 S-ROM TOTAL HIP SYSTEM FEMORAL STEM STANDARD FEMORAL STEM JDI DEPUY ORTHOPAEDICS, INC. 1093330
    36290 ULTAMET METAL ON METAL INSERT METAL ON METAL INSERT KWA DEPUY ORTHOPAEDICS, INC.
    36291 S-ROM M 36MM HEAD +12 HEAD JDI DEPUY ORTHOPAEDICS, INC. XTD-87
    36292 S-ROM M METAL ON METAL FEMORAL HEAD FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. 1806808

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S