BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANTIM TOTAL CONDYLAR TIBIAL INSERT

    MDR report key: 2065639 · Received April 5, 2011

    Report

    Report Number
    MW5020294
    Event Type
    Other
    Date Received
    April 5, 2011
    Date of Event
    January 1, 2010
    Report Date
    April 5, 2011
    Manufacturer
    WRIGHT MED TECHNOLOGY, INC.
    Product Code
    JWH
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I REPRESENT (B)(6). I HAVE BEEN TRYING TO OBTAIN INFO ABOUT MY CLIENT'S FAILED KNEE HARDWARE SINCE (B)(6) 2010. HE UNDERWENT A TOTAL KNEE REPLACEMENT IN 1998 WITH THE HARDWARE LISTED ON THE ATTACHED EXHIBIT "1." UNFORTUNATELY, THE HARDWARE FAILED AND HAD TO BE REMOVED BY (B)(6), M.D. ON (B)(6) 2010. DR. (B)(6) OPERATIVE REPORT IS ATTACHED AS EXHIBIT "2." AS YOU CAN SEE FROM DR. (B)(6) REPORT, WHEN HE EXPLORED (B)(6) KNEE IN THE OPERATING ROOM, HE DISCOVERED THAT THE PROSTHESIS HAD COMPLETELY FRACTURED. DUE TO THIS FAILURE, (B)(6) HAD TO QUIT HIS JOB IN (B)(6) AND RETURN TO THE UNITED STATES TO HAVE THE PROSTHESIS REPLACED. I AM ONCE AGAIN REQUESTING THAT YOU SEND ME THE PROSTHESIS THAT WAS RETURNED TO YOU AFTER DR. (B)(6) OPERATION. IT IS NECESSARY FOR ME TO TEST THE DEVICE TO DETERMINE WHY IT FAILED. AT THIS TIME, I HAVE NOT RECEIVED ANYTHING AT ALL WRIGHT MEDICAL TECHNOLOGY, INC. ON THE OTHER HAND, I HAVE PROVIDED YOU AND YOUR CLIENT WITH ALL OF THE MEDICAL RECORDS PERTAINING TO THE EXPLANTING OF THE HARDWARE. I ASSUME THAT YOU HAVE NO INTENTION OF COMPLYING. IN THIS CONNECTION, I WILL BE SEEKING ASSISTANCE WITH THE U.S. FOOD AND DRUG ADMINISTRATION. PRE AND POSTOPERATIVE DIAGNOSES: FAILED TOTAL KNEE, RIGHT KNEE WITH LOOSE PROSTHESIS AND INTRACTABLE KNEE PAIN. PROCEDURE: REVISION TOTAL KNEE ARTHROPLASTY, RIGHT, BOTH TIBIAL AND FEMORAL COMPONENTS AND PATELLAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTIM TOTAL CONDYLAR TIBIAL INSERT TIBIAL INSERT, LG/LG+ 10MM JWH WRIGHT MED TECHNOLOGY, INC. 038A079446
    2 ADVANTIM SMOOTH TIBIAL STEM TIBIAL STEM, 3" JWH WRIGHT MED TECHNOLOGY, INC. 108A090584
    3 ADVANTIM TOTAL CONDYLAR FEMORAL IMPLANT FEMORAL IMPLANT, LG+/RIGHT JWH WRIGHT MED TECHNOLOGY, INC. 035M219443
    4 ADVANTIM MODULAR STEMMED TIBIAL BASE TIBIAL BASE, LG+ JWH WRIGHT MED TECHNOLOGY, INC. 068A079372
    5 6.5 MM CANCELLOUS SELF-TAPPING BONE SCREW BONE SCREW, 2.5CM LENGTH JWH WRIGHT MED TECHNOLOGY, INC. 068A083472
    6 6.5 MM CANCELLOUS SELF-TAPPING BONE SCREW BONE SCREW, 3.5CM LENGTH JWH WRIGHT MED TECHNOLOGY, INC. 078A088274
    7 6.5 MM CANCELLOUS SELF-TAPPING BONE SCREW BONE SCREW, 2.0 CM LENGTH JWH WRIGHT MED TECHNOLOGY, INC. 038A079291
    8 6.5 MM CANCELLOUS SELF-TAPPING BONE SCREW BONE SCREW, 3.5 CM LENGTH JWH WRIGHT MED TECHNOLOGY, INC. 078A088274

    Patients

    Seq Age Sex Outcome Treatment
    1