BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTICUL/EZE BALL 32 +1 GR

    MDR report key: 12434066 · Received September 7, 2021

    Report

    Report Number
    1818910-2021-19431
    Event Type
    Death
    Date Received
    September 7, 2021
    Date of Event
    August 13, 2021
    Report Date
    August 16, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K883460
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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. H10 ADDITIONAL NARRATIVE: 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. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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

    ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT HAPPENED DURING PRIMARY SURGERY. THERE WERE NO ALLEGED DEFICIENCIES TO THE REPORTED PRODUCTS AND THE AFFECTED SIDE OF THE PATIENT WAS THE LEFT HIP.

    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

    WAS INFORMED BY THE PAVILION ASSISTANT ABOUT AN ADVERSE EVENT THAT OCCURRED IN A SURGERY IN WHICH OUR PRODUCTS WERE USED. IN THE HOSPITAL, THE PATIENT UNDERWENT TOTAL HIP REPLACEMENT SURGERY, IN WHICH A PINNACLE CUP WAS IMPLANTED WITH ALTRX INSERT AND TWO SCREWS, C-STEM CEMENTED STEM, VACUMIX PLUS 80G BONE CEMENT, METAL HEAD. AS REPORTED, AT THE END OF THE SURGERY THE PATIENT BEGAN TO BECOME UNBALANCED AND AFTER SEVERAL RESUSCITATION ATTEMPTS THE PATIENT UNFORTUNATELY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329355 ARTICUL/EZE BALL 32 +1 GR METAL FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US D20111131

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ALTRX +4 10D 32IDX48OD| ALTRX INSERT| C STEM VOID CENTALIZER 12 DM| C-STEM CEMENTED STEM| METAL HEAD| PINN CAN BONE SCREW 6.5MMX15MM| PINN CAN BONE SCREW 6.5MMX30MM| PINN SECTOR W/GRIPTION 48MM| PINNACLE CUP| SCREW| SCREW| VMP + DEPUY CMW 3G 80G| VMP + DEPUY CMW 3G 80G| ALTRX INSERT| C-STEM CEMENTED STEM| METAL HEAD| PINNACLE CUP| SCREW| SCREW| VMP + DEPUY CMW 3G 80G