BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE ACETABULAR CUP SYSTEM 56

    MDR report key: 2883907 · Received December 17, 2012

    Report

    Report Number
    MW5028251
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    December 5, 2007
    Report Date
    November 6, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(6) HAD A TOTAL HIP REPLACEMENT ON (B)(6) 2007. HE RECEIVED THE DEPUY PINNACLE ACETABULAR CUP SIZE 56, A SINGLE 35 MM CANCELLOUS BONE SCREW FOR ACETABULAR FIXATION, A 40MM PINNACLE MEDAL INSERT, A SIZE 4 DEPUY SUMMIT, PROXIMALLY COATED TAPERED FEMORAL STEM WITH HIGH OFFSET, AND A 40MM PLUS 1.5 MM METAL FEMORAL HEAD. PRIOR TO SURGERY, (B)(6) HAD CHRONIC LEFT HIP PAIN AS A RESULT OF DEGENERATIVE JOINT DISEASE. IN THE SUMMER OF 2010, ASC BEGAN EXPERIENCING PRETTY BAD POSTERIOR AND LATERAL HIP PAIN RADIATING DOWN THE SIDE OF HIS THIGH, WITH HIS HIP GIVING OUT ON SEVERAL OCCASIONS. HE ALSO OCCASIONALLY EXPERIENCE GROIN PAIN. ON (B)(6) 2011, (B)(6) WAS SEEN IN THE EMERGENCY ROOM COMPLAINING OF LEFT HIP PAIN AFTER FEELING A "POP". HIS PAIN LEVEL WAS 7/10. ON (B)(6) 2011, HE WAS NOTED TO HAVE SOME SWELLING OVER THE LATERAL ASPECT OF THE HIP. ON (B)(6) 2011, (B)(6) WAS SEEN FOR A SECOND OPINION AND ON (B)(6) 2011, (B)(6) HAD A LEFT HIP REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE ACETABULAR CUP SYSTEM 56 METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1217-22-056 84XG71000
    2 35MM CANCELLEOUS BONE SCREW SCREW HWC DEPUY ORTHOPAEDICS, INC
    3 40MM PINNACLE METAL INSERT INSERT KWA DEPUY ORTHOPAEDICS, INC
    4 4 DEPUY SUMMIT DEPUY HEAD JDI DEPUY ORTHOPAEDICS INC
    5 FEMORAL STEM FEMORAL STEM KWY DEPUY ORTHOPAEDICS INC
    6 40MM FEMORAL HEAD FEMORAL HEAD KWY DEPUY ORTHOPAEDICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R| S