BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CONTINUUM HARD RIM BEARING IMPACTOR

    MDR report key: 1963628 · Received December 21, 2010

    Report

    Report Number
    1822565-2010-01400
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: POSSIBLE CAUSES OF FRACTURE INCLUDE: THE ADAPTER LIP FACE NOT BEING SEATED FLUSH TO THE RIM FACE OF THE LINER DURING IMPACTION, CREATING A POINT LOADING SITUATION AT THE LIP RATHER THAN THE INTENDED FACE LOADING. A SCRATCH OR CHIP MAY HAVE BEEN PLACED ON THE INSTRUMENT DURING CLEANING/STERILIZATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: 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 SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, 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 IMPACTOR PAD FRACTURED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CONTINUUM HARD RIM BEARING IMPACTOR HIP INSTRUMENT HWA ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1