BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L PRESSW-FIR TAPER FEMORAL STEM

    MDR report key: 2690342 · Received August 8, 2012

    Report

    Report Number
    1822565-2012-01682
    Event Type
    Injury
    Date Received
    August 8, 2012
    Date of Event
    June 21, 2012
    Report Date
    July 10, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPONENTS WERE IMPLANTED (B)(6) 2012, AND REVISED (B)(6) 2012, MAKING AN IN-VIVO TIME OF APPROX 2 MONTHS. THE ADVERSE EVENT REPORTED NOTES THAT THE EVENT WAS NOT RELATED TO THE DEVICE. PT HAD A BMI OF (B)(6) ACCORDING TO HEIGHT AND WEIGHT PROVIDED. PRIMARY OPERATIVE NOTES WERE PROVIDED WHICH WERE UNREMARKABLE. REVISION NOTES STATE A WELL FIXED ACETABULUM AND LOOSE FEMORAL STEM WITH PERIPROSTHETIC FRACTURE. PERIPROSTHETIC FRACTURE IS LIKELY DUE TO PT FALL. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC., CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT FELL WHILE CARRYING LAUNDRY DOWN THE STAIRS, THIS RESULTED IN A PERIPROSTHETIC FRACTURE REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L PRESSW-FIR TAPER FEMORAL STEM LZO ZIMMER, INC. 61719289

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention