BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ2

    MDR report key: 11261231 · Received February 1, 2021

    Report

    Report Number
    1818910-2021-02192
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    December 30, 2020
    Report Date
    January 21, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295025764
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EXAMINATION. DEPUY SYNTHESE CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    ON (B)(6) 2020, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE, BOTH COMPONENTS, TO ADDRESS FAILED RIGHT TOTAL KNEE. THE INDICATIONS FOR SURGERY INCLUDED INCREASING VARUS DEFORMITY AND PAIN WITH AMBULATION. PREOPERATIVE RADIOGRAPH WERE NOTED TO BE CONSISTENT WITH TIBIAL SUBSIDENCE AND LOOSENING. DURING THE PROCEDURE IT WAS NOTED THAT THE TIBIAL TRAY HAD SUBSIDED AND WAS GROSSLY LOOSE, NO INTERFACE PROVIDED. THE FEMORAL COMPONENT WAS REVISED, THOUGH IT WAS NOTED TO BE WELL FIXED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    SUBJECT ID: (B)(6), STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY, TO ADDRESS ASEPTIC LOOSENING OF THE TIBIAL TRAY AND FEMUR, PAIN, AND STIFFNESS. DATE OF IMPLANTATION: (B)(6) 2011, DATE OF REVISION: (B)(6) 2020 (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL TRAY, FEMUR, AND TIBIAL INSERT. PRODUCT DETAILS: CATALOG: 3122040, LOT: 3249524, DESCRIPTION: SMART SET MV BONE CEMENT 40G. CATALOG: 3122040, LOT: 3249524, DESCRIPTION: SMART SET MV BONE CEMENT 40G. CATALOG: 129411030, LOT: 3116672, DESCRIPTION: LCS COMPLETE RP POST/STAB FLEXION FEM CEMENTED MED RT. CATALOG: 129433120, LOT: 3155830, DESCRIPTION: MBT CEMENTED KEEL SZ 2. CATALOG: 129409430, LOT: 3254175, DESCRIPTION: LCS COMPLETE PATELLA LOW PROFILE 3 PEGGED CEMENTED MED. CATALOG: 129416310, LOT: CW9DS4000, DESCRIPTION: LCS COMPLETE RPS INSERT MED 10MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158071 MBT CEM KEEL TIB TRAY SZ2 MBT TIBIAL TRAY : KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS INC US 1294-33-120 3155830 10603295025764

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LCS COMP RPS INS MED 10MM| LCS COMP RPSFLEX FEM CEM R MED| LCS COMPLETE LO PRO POLPAT MED| MBT CEM KEEL TIB TRAY SZ2| SMARTSET MV 40G - EO| SMARTSET MV 40G - EO