BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PSL-HA CLUSTER ACETABULAR SHELL

    MDR report key: 2434161 · Received January 24, 2012

    Report

    Report Number
    9616680-2012-00059
    Event Type
    Injury
    Date Received
    January 24, 2012
    Date of Event
    December 22, 2008
    Report Date
    January 4, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWB
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE INFORMATION CONTAINED IN THIS REPORT WAS EXTRACTED FROM MAUDE REPORT MW5023413, AND ONLY PERTAINS TO THE SECTIONS THAT INVOLVE STRYKER DEVICES. IT WAS REPORTED THAT, "IN 2005, AN MRI OF MY LEFT HIP WAS PERFORMED DUE TO LEFT HIP PAIN. THE IMPRESSIONS ARE AS FOLLOWS: THERE IS AN ASYMMETRIC DEGENERATIVE DISEASE INVOLVING THE LEFT HIP JOINT DIFFUSELY. THERE ARE SEVERAL FOCAL CARTILAGE DEFECTS INVOLVING THE SUPERIOR AND MEDIAL ASPECTS OF THE LEFT FEMORAL HEAD SURFACE. A VERY SMALL LEFT HIP EFFUSION IS PRESENT AS WELL. IT IS SUGGESTIVE OF A PRIMARY BASED SYNOVIAL NATUROPATHY. IN 2008, A TOTAL HIP REPLACEMENT WAS PERFORMED. THE IMPLANTS WERE TRIDENT PSL-HA CLUSTER ACETABULAR SHELL OF STRYKER. IN 2008, A REVISION ACETABULAR COMPONENT, LEFT TOTAL HIP CONSTRUCT AND EXCHANGE OF FEMORAL HEAD. THE IMPLANTS WERE THE CLUSTER ACETABULAR SHELL TRIDENT PSL HA. THREE FIXATION SCREWS WERE NOTED, TWO IN THE SUPERIOR LIP OF THE ACETABULUM AND SECOND EXTENDING INTO THE SOFT TISSUE PELVIS ADJACENT TO THE PELVIC BRIM. CONSTRAINED LINER IS SEEN. IN 2010, ANOTHER BONE SCAN WAS PERFORMED. THE IMPRESSION ARE AS FOLLOWS: BONE SCAN FINDINGS COMPATIBLE WITH PROSTHETIC LOOSENING WITH POSSIBLE NEW BONE TRAUMA AT THE MID RIGHT TIBIA. LOOSENING OF THE LEFT HIP PROSTHESIS IS NOT EXCLUDED. SHE ALSO HAS A WEAKNESS WITH AVERSION LIKELY DUE TO NEUROPATHY AT THE PERONEAL NERVE. THIS WAS EVIDENCED BY EMG DONE LAST YEAR. THE LEFT HIP APPEARS STABLE, HOWEVER, DUE TO MEDIAL AND SUPERIOR PLACEMENT, SHE LIKELY HAS PAIN FROM SLIGHT MALPOSITIONING OF THE CUP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PSL-HA CLUSTER ACETABULAR SHELL IMPLANT KWB STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R