BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT M/S PSL SHELL 40MM

    MDR report key: 4221792 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04148
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K903636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE SHELL REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT AS IT WAS STATED THAT THE DISLOCATION OCCURRED DUR TO LINER WEAR AND NOT THE SHELL. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (X-RAYS, MEDICAL RECORDS, OPERATIVE NOTES) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE DISPOSED OF AT HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED AT ORTHOPEDIC SURGERY VOL.65 NO.11. THE LEFT THA WITH OMNIFIT PSL CUP AND OMNIFIT SERIES 2 INSERT WAS DONE AT AROUND 15 YEARS BEFORE. THE PATIENT FELT SOMETHING WAS WRONG IN THE HIP FROM AROUND 14 YEARS AFTER SURGERY. THE PAIN AND WEAKNESS HAD EMERGED AROUND 15 YEARS AFTER SURGERY WHEN SHE STANDS UP FROM A SITTING POSITION. SHE WAS NOT ABLE TO WALK, BECAUSE SHE HAD PAIN AND SHORTENING OF THE LEFT LOWER LEG. THEREFORE REVISION SURGERY OF THE CUP, INSERT AND HEAD WERE DONE BECAUSE THE CUP DEFICIENT IN THE FORM OF A FEMORAL HEAD, THE LINER WAS WORN AND DISLOCATED FROM THE CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED AT ORTHOPEDIC SURGERY VOL.65 NO.11. THE LEFT THA WITH OMNIFIT PSL CUP AND OMNIFIT SERIES 2 INSERT WAS DONE AT AROUND 15 YEARS BEFORE. THE PATIENT FELT SOMETHING WAS WRONG IN THE HIP FROM AROUND 14 YEARS AFTER SURGERY. THE PAIN AND WEAKNESS HAD EMERGED AROUND 15 YEARS AFTER SURGERY WHEN SHE STANDS UP FROM A SITTING POSITION. SHE WAS NOT ABLE TO WALK, BECAUSE SHE HAD PAIN AND SHORTENING OF THE LEFT LOWER LEG. THEREFORE REVISION SURGERY OF THE CUP, INSERT AND HEAD WERE DONE BECAUSE THE CUP DEFICIENT IN THE FORM OF A FEMORAL HEAD, THE LINER WAS WORN AND DISLOCATED FROM THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703974 OMNIFIT M/S PSL SHELL 40MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention