BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ2.5

    MDR report key: 4091551 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28135
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    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

    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

    THE DEVICE ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, 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

    PROCEDURE: KNEE REVISION PERFORMED ON (B)(6) 2014. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2004. REVISION WAS PERFORMED DUE TO LOOSE TIBIAL COMPONENT. COMPONENTS REVISED TO MBT REVISION TIBIA AND SLEEVE STEM COMBO. PREOPERATIVE X-RAYS AND PHOTO OF INSERT AVAILABLE. PATIENT INITIALS (B)(6), FEMALE, WEIGH (B)(6)KG. NO FURTHER INFORMATION AVAILABLE. (B)(6) 2014 - EMAIL RECEIVED FROM (B)(6) ADVISING OF THE FOLLOWING; ADDITIONAL INFORMATION RECEIVED FROM (B)(6) ON (B)(6) 2014: THE DAMAGE MEDIAL POSTERIOR ASPECT WAS APPARENT ON REMOVAL. THE INSERT, HOWEVER, IS NOT THE ISSUE. DOCTOR HAS HAD A NUMBER OF TIBIAL REVISIONS DUE TO CEMENT NOT BONDING TO THE TIBIAL TRAY. HE USES ROUTINELY CMW 2. HE IS VERY EXPERIENCED HAVING DONE WELL OVER A 1000 PFC RP KNEE REPLACEMENTS. THERE WAS NO PRIOR TRAUMA ONLY PAIN DUE TO THE LOOSE TIBIAL COMPONENT. THE TRAY LIFTED OUT WITH NO CEMENT BOND TO IMPLANT. IT MAY BE WORTH LOOKING AT PRIOR COMPLAINTS UNDER HIS NAME AS HE HAS NOW DONE A NUMBER OF REVISIONS FOR THE SAME REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571219 MBT CEM KEEL TIB TRAY SZ2.5 KNEE TIBIAL TRAY NJL DEPUY IRELAND 9616671 1211756

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention