BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CPT STEM

    MDR report key: 2082888 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01060
    Event Type
    Injury
    Date Received
    May 3, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A JOURNAL ARTICLE. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; HOWEVER, THE ARTICLE STATED THAT X-RAYS WERE REVIEWED AND FOUND AN ABDUCTION ANGLE OF 51 DEGREES AND ANTEVERSION ANGLE OF 8 DEGREES. THE SURGICAL TECHNIQUE INSTRUCTS THE USER TO IMPLANT THE SHELL AT 45 DEGREES ABDUCTION AND 20 DEGREES ANTEVERSION. PATIENT WAS DESCRIBED AS (B)(6), FEMALE, WITH A (B)(6). PATIENT ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. WITH THE INFORMATION PROVIDED, THE ROOT CAUSE FOR THE PAIN, SUBSIDENCE OF THE FEMORAL COMPONENT, AND OSTEOLYSIS CANNOT BE DEFINITIVELY DETERMINED. DETAILS OF THE EVENTS LEADING UP TO THE FALL ARE UNKNOWN. THE CAUSE OF THE FEMORAL FRACTURE AND REVISION MAY BE DUE TO THE PATIENT FALL. WITH THE INFORMATION PROVIDED, A ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT TWELVE YEARS AFTER PRIMARY THA, THE PATIENT DEVELOPED PAIN ASSOCIATED WITH SUBSIDENCE OF THE FEMORAL COMPONENT AND OSTEOLYSIS. ONE YEAR LATER, SHE FELL AND SUSTAINED A PERIPROSTHETIC FEMUR FRACTURE, WHICH WAS TREATED WITH REVISION. THE LINER WAS WORN, BUT THE SHELL WAS WELL FIXED AND RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CPT STEM HIP PROSTHESIS KWY ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention LOT# UNK| UNK ELEVATED RIM LINER: CATALOG # UNK,