BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIS COLLARED STD SIZE 5

    MDR report key: 20962142 · Received December 18, 2024

    Report

    Report Number
    1818910-2024-25593
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 27, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    MEH
    PMA / PMN Number
    K202472
    Product Problem
    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). INVESTIGATION SUMMARY. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, "IT WAS REPORTED THAT THIS PATIENT WAS HAVING A LEFT TOTAL HIP. DURING OPENING OF THE DEFINITIVE ACTIS STEM, THE NURSE AND SURGICAL TECH STRUGGLED OPENING THE IMPLANT OUT OF THE PLASTIC PACKAGING. THE PACKAGING IS VERY DIFFICULT TO OPEN. THE NEW PACKAGING IS NOT AN IMPROVEMENT, AND IS HORRIBLE TO OPEN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY." PRODUCT DESCRIPTION:- ACTIS COLLARED STD SIZE 5 PRODUCT CODE:- 101011050 LOT NO:- 4221576 QUANTITY OF MANUFACTURED:- 09 DATE OF MANUFACTURING:- 05-JUL-2023 EXPIRY DATE:- N/A 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 PRODUCT DESCRIPTION:- ACTIS COLLARED STD SIZE 5 PRODUCT CODE:- 101011050 LOT NO:- 4221576 QUANTITY OF MANUFACTURED:- 09 DATE OF MANUFACTURING:- 05-JUL-2023 EXPIRY DATE:- N/A DEVICE HISTORY REVIEW. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A LEFT TOTAL HIP PROCEDURE. DURING OPENING OF THE DEFINITIVE ACTIS STEM, THE NURSE AND SURGICAL TECH STRUGGLED OPENING THE IMPLANT OUT OF THE PLASTIC PACKAGING. THE PACKAGING IS VERY DIFFICULT TO OPEN. THE NEW PACKAGING IS NOT AN IMPROVEMENT. THERE WAS A 30 SECOND DELAY IN SURGERY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455889 ACTIS COLLARED STD SIZE 5 HIP FEMORAL STEM MEH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female