BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE-THIRD TUBULAR PLATE WITH COLLAR 10 HOLES

    MDR report key: 1252425 · Received December 3, 2008

    Report

    Report Number
    1822565-2008-00867
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    June 7, 2007
    Report Date
    November 3, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN AS TO HOW MANY SCREWS WERE USED AND HOW THE FIXATION OF THE PLATE WAS MADE TO THE ANKLE BONE. THERE WERE NO DEVICES RETURNED FOR EVALUATION. ALSO, NO X-RAYS OR PHOTOS WERE RETURNED. PATIENT MIGHT HAVE EXPERIENCED PAIN DUE TO INADEQUATE HEALING OF THE BONE OR NON-COMPLIANCE REASONS. PATIENT WEIGHT MIGHT HAVE ALSO CONTRIBUTED TO THIS EVENT. BASED ON THE AVAILABLE INFORMATION THE CAUSE CAN NOT BE DEFINITELY DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO 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. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REVIEWED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT RIGHT ANKLE SURGERY IN 2006. POST-OP, PATIENT WAS EXPERIENCING PAIN AND UNDERWENT SURGERY TO REMOVE THE SYNDESMOSIS SCREW, WHICH HAD FRACTURED FOUR MONTHS LATER. THEREAFTER, PATIENT WAS EXPERIENCING PAIN, AND X-RAYS TAKEN IN 2007, SHOWED THE LATERAL PLATE HAD BROKEN. REMOVAL OF THE FRACTURED PLATE, SCREWS AND WIRES FROM RIGHT ANKLE WAS PERFORMED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE-THIRD TUBULAR PLATE WITH COLLAR 10 HOLES TRAUMA PROSTHESIS HRS ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R