BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL CLAMP

    MDR report key: 6456222 · Received April 4, 2017

    Report

    Report Number
    1038671-2017-00212
    Event Type
    Injury
    Date Received
    April 4, 2017
    Date of Event
    March 20, 2017
    Report Date
    February 4, 2019
    Manufacturer
    EXACTECH, INC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED HAVE BEEN UPDATED ACCORDINGLY. ACCORDING TO LABELING REVIEW IT IS WELL KNOWN THAT AS PART OF THE PREOPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURGERY AND/OR POSTOPERATIVE PERIOD. IT IS A KNOWN RISK OF TOTAL JOINT SURGERIES THAT THERE MAY BE THE NEED FOR SURGICAL REVISIONS OR INTERVENTIONS FOR DIFFERENT CAUSES AND CONDITIONS. ALSO, THERE ARE DEVICE SPECIFIC RISKS OF FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROTHESIS OR ANY OF ITS COMPONENTS, AND ANY OF WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE MOST LIKELY CAUSE OF THE FRACTURED FEMUR DURING A KNEE SURGICAL PROCEDURE IS RELATED TO THE SURGICAL TECHNIQUE AND PATIENT POOR METAPHYSEAL BONE QUALITY. THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. NO INFORMATION HAS BEEN PROVIDED. ASKED, NOT ANSWERED. CORRECTED DATA: NOT A FACILITY. NO DEVICE EVALUATION PENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SURGEON EXPERIENCED A CRACK TO A PATIENT'S FEMUR WHILE USING A FEMORAL CLAMP DURING KNEE SURGERY. PATIENT INFORMATION WAS NOT OBTAINED, ASKED BUT NOT ANSWERED. THERE ARE PRE AND POST-OPERATIVE X-RAYS IN THE FILE, THE PATIENT CLEARLY HAS A RIGHT EXISTING TOTAL KNEE ARTHROPLASTY, THE REASON FOR A REVISION OR PARTS REPLACED WERE NOT OBTAINED, ASKED, BUT NOT ANSWERED. IN THE OPINION OF THE SURGEON THE FEMUR PROBABLY CRACKED DUE TO POOR METAPHYSEAL BONE QUALITY. THE PATIENT HAD A LARGE CEMENT PLUG IN THE FEMORAL CANAL FROM A PRIMARY KNEE IMPLANT, IT WAS STATED TO BE AT LEAST 80 MM DEEP. INITIALLY THE SURGEON WAS PLANNING TO USE A SHORT STEM TO AVOID THE CEMENT PLUG BUT DECIDED TO GO LONGER. WHILE PREPARING THE CANAL FOR THE LONGER STEM, THE BONE FRACTURED. THE SURGEON REPAIRED THE FEMORAL FRACTURE WITH A FEMORAL GRAFT. THERE IS NO COMPLAINT OR ALLEGATION OF DEVICE MALFUNCTION. INFORMATION WAS REQUESTED, AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    A CRACK IN THE PATIENT'S FEMUR WAS GENERATED WHILE USING THE FEMORAL CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241024 FEMORAL CLAMP CLAMP LXH EXACTECH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention