BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+

    MDR report key: 4950371 · Received July 24, 2015

    Report

    Report Number
    3005673311-2015-00079
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Report Date
    July 23, 2015
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    JHW
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE AND INVOLVED COMPONENTS NN260P AND NN620 ARE NOT MARKETED IN THE U.S. HOWEVER, SIMILAR DEVICES ARE. ADDITIONALLY, COMPONENT INVOLVED NN036K IS MARKETED IN THE U.S. 510(K): K022672. MANUFACTURING SITE EVALUATION: COMPONENT NN674K WAS RECEIVED FOR EVALUATION. THE TIBIA PLATEAU DISPLAYED NO INDICATIONS OF THE ADHERENCE OF BONE CEMENT. COMPONENT NN036K WAS RECEIVED FOR EVALUATION. THIS COMPONENT IS PLASMAPORE-COATED. THERE IS NO INDICATION OF OSSEOINTEGRATION ON THE IMPLANT. THE LACK OF BONE CEMENT / OSSEOINTEGRATION ON THE RECEIVED IMPLANTS MAY HAVE BEEN REMOVED DURING EXPLANTATION OR DURING CLEANING OF IMPLANTS PRIOR TO RETURN. QUALITY AND PRODUCTION DOCUMENTS WERE REVIEWED FOR REPORTED BATCH NUMBERS, THERE WERE NO INDICATIONS OF A MATERIAL OR MANUFACTURING DEFECT. RESULTS: IT APPEARS THAT THE BONE CEMENT DID NOT ADHERE WITH THE BONE AND THE IMPLANT AS INTENDED. THIS MAY RESULT IN A LOOSENING. THERE ARE MANY FACTORS THAT MAY LEAD TO NONEXISTING OSSEOINTEGRATION OR NON-ADHERENCE OF BONE AND BONE CEMENT, THIS INCLUDES: INCORRECT APPLICATION OF THE BONE CEMENT; POLLUTION OF THE SURFACE OF THE IMPLANT (BLOOD, WATER, ETC); ALLERGIC REACTION OF THE BONE CEMENT OR IMPLANT; USE OF NO OR TOO LITTLE BONE CEMENT; OR, RECOVERY DISORDER- DAMAGED BONE MAY BE DECOMPOSED AND REMOVED FROM THE IMPLANT RETROACTIVELY. IN CASES OF EARLY LOOSENING OF AN IMPLANT IT IS POSSIBLE THAT THE LOOSENING OCCURRED DUE TO SEPSIS. COMPONENT NN260P WAS RECEIVED AND DETERMINED TO BE ACCORDING TO SPECIFICATION AND UNRELATED TO THE REPORTED INCIDENT. COMPONENT NN620 WAS RECEIVED AND DETERMINED TO BE ACCORDING TO SPECIFICATION AND UNRELATED TO THE REPORTED INCIDENT. BASED ON THE INFORMATION RECEIVED AND THE EVALUATION OF ALL COMPONENTS ROOT CAUSE FOR THE LOOSENING OF THE IMPLANT CAN NOT BE DETERMINED. THERE WERE NO MATERIAL OR MANUFACTURING DEFECTS FOUND IN ANY OF THE COMPONENTS. CORRECTIVE AND PREVENTIVE ACTION: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). POST OPERATIVE LOOSENING OF TIBIAL COMPONENT. PATIENT EXPERIENCED PAIN IN SUPPORT, LOCATED ON ANTEROMEDIAL TIBIA FACE. PROBABLE LOOSENING OF THE TIBIAL COMPONENT. FIBROUS INTERPOSITION 1CM ON THE INNER POSTERIOR TIBIAL PROSTHESIS, BRITTLE SUBCHONDRAL BONE ON EXTERNAL TIBIAL PROSTHESIS, EXTERNAL TIBIAL IMPLANT AND EXTERNAL NECK. RELATED COMPONENTS: NN260P / PLUG F/TIBIAL PLATEAU. BATCH # 51868498. NN036K / COLUMBUS CR FEMORAL COMP. PLASMAPORE F6R. BATCH # 51796372. NN620 / COLUMBUS UCR GLIDING SURFACE T2/2+ 10MM. BATCH # 51839005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483821 COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+ KNEE ENDOPROSTHESES JHW AESCULAP AG & CO. KG NN674K 51791848

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other