BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ATTUNE FEMORAL

    MDR report key: 19536854 · Received June 14, 2024

    Report

    Report Number
    1818910-2024-12839
    Event Type
    Injury
    Date Received
    June 14, 2024
    Report Date
    June 13, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. THE CITATION OF THE ARTICLE HAS BEEN PROVIDED: KLEEMAN LT, OWENS JM, JOHNSON RM, CLARY CW, ELKINS JM, DENNIS DA. CLINICAL AND COMPUTATIONAL EVALUATION OF AN ANATOMIC PATELLAR COMPONENT. J ARTHROPLASTY. 2024 MAY 10:S0883-5403(24)00438-8. DOI: 10.1016/J.ARTH.2024.05.007. EPUB AHEAD OF PRINT. PMID: 38735546. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. CORRECTED: H8.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KLEEMAN LT, OWENS JM, JOHNSON RM, CLARY CW, ELKINS JM, DENNIS DA. CLINICAL AND COMPUTATIONAL EVALUATION OF AN ANATOMIC PATELLAR COMPONENT. J ARTHROPLASTY. 2024 MAY 10:S0883-5403(24)00438-8. DOI: 10.1016/J.ARTH.2024.05.007. EPUB AHEAD OF PRINT. PMID: 38735546. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: ANATOMIC PATELLAR COMPONENTS FOR TOTAL KNEE ARTHROPLASTY (TKA) HAVE DEMONSTRATED FAVORABLE IN VIVO KINEMATICS. A NOVEL FAILURE MECHANISM IN PATIENTS IMPLANTED WITH ANATOMIC PATELLA COMPONENTS WAS OBSERVED, PROMPTING A CLINICAL AND COMPUTATIONAL INVESTIGATION TO IDENTIFY PATIENT AND IMPLANT-RELATED FACTORS ASSOCIATED WITH SUBOPTIMAL PERFORMANCE. METHODS: A RETROSPECTIVE EVALUATION WAS PERFORMED COMPARING 100 TKA PATIENTS IMPLANTED WITH ANATOMICAL VERSUS 100 SEX-, AGE-, AND BMI-MATCHED PATIENTS IMPLANTED WITH DOME PATELLAR COMPONENTS. ALL WERE IMPLANTED WITH THE SAME POSTERIOR-STABILIZED (PS) TKA SYSTEM WITH A MINIMUM 1-YEAR FOLLOW-UP DURATION. SEVERAL RADIOGRAPHIC PARAMETERS WERE ASSESSED. A SEPARATE COMPUTATIONAL EVALUATION WAS PERFORMED USING FINITE-ELEMENT ANALYSIS, COMPARING COMPONENTS. BONE STRAIN ENERGY DENSITY WAS MEASURED AT THE PROXIMAL AND DISTAL PATELLAR POLES. FROM THIS COHORT, THERE WERE 10 KNEES IN 9 PATIENTS THAT REQUIRED PATELLA REVISION WITH CONFIRMED FAILURE OF THE ANATOMIC PATELLAR COMPONENT (1.2% OF THE STUDY POPULATION). RESULTS: PATIENTS WHO HAD ANATOMIC PATELLAR COMPONENTS HAD A SIGNIFICANTLY HIGHER PREVALENCE OF ANTERIOR KNEE PAIN (AKP; 18 VERSUS 2%, P < 0.001), CHRONIC EFFUSIONS (18 VERSUS 2%, P < 0.001), AND SUPERIOR PATELLAR POLE FRAGMENTATION (36 VERSUS 13%, P < 0.001) VERSUS THOSE WHO HAD DOME PATELLAR COMPONENTS. THE ANATOMIC GROUP ALSO DEMONSTRATED MORE LATERAL PATELLAR SUBLUXATION (2.3 VERSUS 1.1 MM, P < 0.001) AND LATERAL TILT (5.4 VERSUS 4.0 MM, P = 0.013). THERE WAS A HIGHER, BUT NOT SIGNIFICANT, NUMBER OF REVISIONS IN THE ANATOMIC GROUP (7 VERSUS 3, P = 0.331). IN COMPUTATIONAL EVALUATION, ALL SIMULATIONS DEMONSTRATED INCREASED BONE STRAIN ENERGY DENSITY AT THE SUPERIOR PATELLAR POLE FOR THE ANATOMIC PATELLA. RESECTION THICKNESS < 13 MM RESULTED IN AN OVER 2-FOLD INCREASE IN STRAIN ENERGY DENSITY, WHILE A NEGATIVE 7° RESECTION ANGLE RESULTED IN A 6-FOLD HIGHER SUPERIOR POLE STRAIN ENERGY. CONCLUSION: PATIENTS WHO HAD THIS DESIGN OF ANATOMIC PATELLAR COMPONENT SHOWED HIGHER RATES OF AKP, EFFUSION, AND SUPERIOR POLE FRAGMENTATION THAN PATIENTS WHO HAD DOME PATELLAE, WITH HIGHER SUPERIOR PATELLA POLE STRAIN ENERGY CONFIRMED ON COMPUTATIONAL EVALUATION. AVOIDING HIGHER RESECTION ANGLES AND EXCESSIVE PATELLAR RESECTION MAY IMPROVE THE PERFORMANCE AND SURVIVORSHIP OF THE ANATOMIC PATELLA. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ATTUNE PATELLA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE KNEE PATELLA: QTY 4 ISOLATED PATELLA LOOSENING TREATED WITH REVISION. QTY 1 EXTENSOR LAG WITH ARTHROFIBROSIS TREATED WITH REVISION. QTY 1 PATELLA FAILURE FOLLOWING A TRAUMATIC FALL TREATED WITH REVISION. QTY 1 TRAUMATIC ARTHROTOMY DEHISCENCE TREATED WITH REVISION. QTY 1 PERIPROSTHETIC INFECTION TREATED WITH IRRIGATION AND DEBRIDEMENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE KNEE PATELLA: FIGURE 1A-E DISPLAYS A PATIENT IS 63 YEAR OLD ACTIVE MALE HAD 2+ KNEE EDEMA ON EXAM AND LATERAL RADIOGRAPHS SHOWED SUPERIOR PATELLAR POLE FRAGMENTATION WITH EARLY LUCENCY. THE LUCENCY PROGRESSED AT TWO YEARS POST-OP ON BOTH VIEWS WITH WORSENING SUBJECTIVE PAIN. PATIENT UNDERWENT REVISION OF HIS PATELLA 2.1 YEARS FOLLOWING INDEX TKA. INTRAOPERATIVELY, THE PATIENT HAD BONE AVULSION AT SUPERIOR PATELLA POLE WITH PROLIFERATIVE SYNOVITIS AT DISTAL QUADRICEPS AND BONEY DEFECT AT SUPERIOR PATELLA REMNANT AFTER REMOVAL OF PATELLAR COMPONENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE KNEE TIBIAL TRAY: QTY 3 TOTAL ASEPTIC TIBIAL LOOSENING TREATED WITH REVISION. QTY 1 TRAUMATIC ARTHROTOMY DEHISCENCE TREATED WITH REVISION. QTY 1 PERIPROSTHETIC INFECTION TREATED WITH IRRIGATION AND DEBRIDEMENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE KNEE TIBIAL INSERT: QTY 1 TRAUMATIC ARTHROTOMY DEHISCENCE TREATED WITH REVISION. QTY 1 PERIPROSTHETIC INFECTION TREATED WITH IRRIGATION AND DEBRIDEMENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE FEMORAL: QTY 1 EXTENSOR LAG WITH ARTHROFIBROSIS TREATED WITH REVISION. QTY 1 TRAUMATIC ARTHROTOMY DEHISCENCE TREATED WITH REVISION. QTY 1 PERIPROSTHETIC INFECTION TREATED WITH IRRIGATION AND DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183841 UNK ATTUNE FEMORAL KNEE FEMORAL IMPLANT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention