BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIS COLLARED HIGH SIZE 8

    MDR report key: 22439269 · Received July 8, 2025

    Report

    Report Number
    1818910-2025-11589
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 19, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MEH
    UDI-DI
    10603295380603
    PMA / PMN Number
    K202472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿IT WAS REPORTED THAT THE 8 HIGH OFFSET STEM WAS OPEN AND ONE OF THE INNER PACKAGES WAS NEVER SEALED OR STERILIZED. THEY CAN SEE ON THE PACKAGE THAT ONE SIDE WAS NEVER "PRESSED CLOSED", IT WAS JUST LEFT WIDE OPEN. IT WILL BE HAVING OFFICE SEND BACK THE STEM AND PACKAGING ASAP¿. THE ACTIS COLLARED HIGH SIZE 8 (LOT. 4800140) RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE COMPLAINT UNIT WAS FORWARDED TO THE MANUFACTURING SITE FOR FURTHER EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE OUTER POUCH (SECONDARY STERILE BARRIER) WASN¿T VACUUM SEALED; THE POUCH DOES NOT HAVE ANY EVIDENCE OF HEAT SEALED APPLICATION TO IT. HOWEVER, EVEN IF THE INTEGRITY OF THE SECONDARY BARRIER SEAL WAS COMPROMISED, IT WOULD BE EXPECTED THAT THE INNER PACKAGING WOULD NOT BE APPRECIABLY CONTAMINATED AS MICROBIAL BIOBURDEN ON PACKAGING IS PRIMARILY INTRODUCED THROUGH DIRECT CONTACT (HANDLING). AS SUCH, WHILST THERE IS ADDITIONAL RISK OF INTRODUCING CONTAMINATION TO THE SURGICAL SUITE AS A RESULT OF THE SECONDARY STERILE BARRIER BEING COMPROMISED, THE RISK SHOULD BE CONSIDERED LOW. THE MANUFACTURING INVESTIGATION CONFIRMED THAT THE REPORTED CONDITION WAS ATTRIBUTABLE TO A MANUFACTURING ISSUE RELATED TO HUMAN ERROR DUE TO BREAKDOWN IN VISUAL INSPECTION OF THE OUTER POUCH. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ACTIS COLLARED HIGH SIZE 8 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH DEPUY SYNTHES QUALITY SYSTEM. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE" ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [101012080 /4800140] AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. HOWEVER AN NC WAS RAISED TO ADDRESS THE REPORTED ISSUE. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [101012080 /4800140] AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. HOWEVER AN NC WAS RAISED TO ADDRESS THE REPORTED ISSUE. ADDED: D4 (EXPIRY DATE), H4. CORRECTED: D4 (PRIMARY UDI), H3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ON (B)(6) 2025. DURING THE PROCEDURE, THE 8 HIGH OFFSET STEM WAS OPEN AND ONE OF THE INNER PACKAGES WAS NEVER SEALED OR STERILIZED. IT COULD BE SEEN ON THE PACKAGE THAT ONE SIDE WAS NEVER "PRESSED CLOSED;" IT WAS JUST LEFT WIDE OPEN. THE STEM DID NOT ENTER THE STERILE FIELD. AFFECTED SIDE: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966295 ACTIS COLLARED HIGH SIZE 8 HIP FEMORAL STEM MEH DEPUY ORTHOPAEDICS INC US 4800140 10603295380603

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown