BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT REVISION CEM TIB TRAY SZ 2

    MDR report key: 4121284 · Received September 26, 2014

    Report

    Report Number
    1818910-2014-28882
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE FRACTURED PROXIMAL LATERAL TIBIA BASED ON THE PROVIDED INFORMATION. THE PATIENT BONE QUALITY IS UNKNOWN. THE DEPUY WARSAW INVESTIGATION COULD NOT DETERMINE WHY THE REPORTED SURGICAL INSTRUMENTS WERE NOT AVAILABLE AT SURGERY. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR TO THE REPORTED FRACTURED PROXIMAL LATERAL TIBIA AND THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE REVISION WAS PERFORMED ON (B)(6) 2014 DUE TO THE INFECTION. THE SURGERY WAS CONDUCTED WITH THE COMBINATION OF ¿MBT REVISION TRAY #2¿, ¿MBT SLEEVE 37MM¿ AND ¿STEM12 X 75MM¿. AFTER THE INFECTED IMPLANT BY ANOTHER MANUFACTURE WAS REMOVED AND CEMENT CONTAINING ANTIBIOTICS WAS POURED, AFOREMENTIONED IMPLANTS WERE INSERTED TO THE TARGET LESION SITE. HOWEVER, BEFORE REACHING THE PLANNED LEVEL, THE PROXIMAL LATERAL TIBIA WAS CRACKED. AFTER HAVING CONSULTED THE SURGEON, IT WAS CONCLUDED THAT FURTHER HAMMERING WAS RISKY, SO THE PLAN WAS CHANGED TO USE THE 29MM SLEEVE RATHER THAN THAT OF 37MM. AS WE DID NOT PROVIDE OUR ORIGINAL TRAY REMOVERS FOR THE HOSPITAL, A BONE HAMMER AND HOSPITAL-OWNED ELEVATORIUM HAD TO BE USED TO HIT FROM THE BACK OF THE TRAY, FOR THE REMOVAL. DESPITE THE EFFORTS TO SEPARATE THE TRAY AND THE SLEEVE AFTER THE REMOVAL, THE HOSPITAL¿S INSTRUMENT HAD TO BE USED ALTERNATIVELY DUE TO A LACK OF SPECIAL REMOVERS. DESPITE THE EFFORTS MADE FOR MORE THAN 30 MINUTES, THEY WERE TOO TIGHT TO BE SEPARATED. EVENTUALLY THE ATTEMPT HAD TO BE ABANDONED BECAUSE THE SURGERY COULD NOT TAKE ANY LONGER. SINCE THE TRAY #2 ATTACHED WITH 37MM SLEEVE COULD NOT BE IMPLANTED, THE TRAY #1.5 WITH THE SLEEVE 29MM WAS USED AS AN ALTERNATIVE. (NO CHANGE TO 12X75 STEM) DUE TO A LACK OF THE APPROPRIATE INSTRUMENTS, THE SURGERY DELAYED FOR 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601790 MBT REVISION CEM TIB TRAY SZ 2 KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS, INC. 510970

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention