BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 3 CEM

    MDR report key: 7578794 · Received June 7, 2018

    Report

    Report Number
    1818910-2018-61605
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    January 4, 2017
    Report Date
    May 11, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042372
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO PRODUCT ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES 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. H10 ADDITIONAL NARRATIVE: ADDED: H6. H6 PATIENT CODE: NO CODE AVAILABLE (3191) WAS USED TO CAPTURE SURGICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> NO PRODUCT ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES 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. 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

    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

    (B)(4). THESE INFORMATION HAS BEEN REPORTED IN (B)(4) WITH AN MFR NUMBER 1818910-2019-112845 . MFR NUMBER 1818910-2019-112845 HAS BEEN RETRACTED DUE TO A DUPLICATE OF THIS MFR REPORT # 1818910-2018-61605.

    Description of Event or Problem · 1

    REVIEWED MEDICAL RECORDS RECEIVED ON (B)(6) 2018. RECORDS INDICATED PATIENT'S LEFT ATTUNE KNEE WAS REVISED TO ADDRESS PAIN, CATASTROPHIC VARUS DEFORMITY FROM IMPLANT COLLAPSE, AND ASEPTIC LOOSENING OF THE TIBIAL BASE PLATE, AT THE CEMENT TO IMPLANT INTERFACE. SURGEON INDICATED TIBIAL BASE PLATE COMPONENT WAS GROSSLY LOOSE. STATED THERE WAS TIBIA BONE LOSS WHERE THE TIBIA WAS IMPACTED BY THE LOOSE COMPONENT. TIBIAL CEMENT MANTLE WAS WELL-FIXED, AS WAS THE REVISED FEMUR COMPONENT. INDICATED THAT THERE WAS MILD POLY-WEAR TYPE SYNOVITUS. REPORTED THAT THE PATIENT'S NATIVE PATELLA HAD NOT BEEN RESURFACED WHEN THE PRIMARY WAS PERFORMED. THERE WAS NO EVIDENCE OF ACUTE INFECTION. COMPETITOR BONE CEMENT USED FOR PRIMARY. DOI: (B)(6) 2014; DOR: (B)(6) 2017; (LEFT KNEE).

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO TIBIAL TRAY MIGRATION, MALPOSITIONING, AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED EFFUSION, MILD POLY WEAR-TYPE SYNOVITIS, AND TIBIAL BONE LOSS. THE PATELLA WAS NOT RESURFACED DURING THE PRIMARY OPERATION. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: (B)(6) 2017; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421490 ATTUNE FB TIB BASE SZ 3 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 1506-00-003 6299344 10603295042372

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention COMPETITOR BONE CEMENT