BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE SECTOR II CUP 50MM

    MDR report key: 18585998 · Received January 26, 2024

    Report

    Report Number
    1818910-2024-01786
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    January 18, 2024
    Report Date
    January 26, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295009818
    PMA / PMN Number
    P070026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "HOLE ELIMINATOR WENT STRAIGHT THROUGH THE CUP. SURGEON SAID IT DIDN¿T EVEN FEEL THE THREADS COME TOGETHER. COULDN¿T GET THE HOLE ELIMINATOR OUT OF THE PATIENT WITHOUT REMOVING THE CUP. DECIDED TO LEAVE THE HOLE ELIMINATOR IN THE PATIENT. CUP WAS CONSIGNMENT, HOLE ELIMINATOR WAS LOAN". THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT "IMG_9698.PNG". REVIEW OF THE PHOTOGRAPHIC EVIDENCE REVEALED THE PATIENTS LABELS OF THE INVOLVED IMPLANTS, ONLY THE PRODUCT CODE AND LOT NUMBER OF THE PINNACLE SECTOR II CUP 50MM WERE OBSERVED. NO OTHER OBSERVATION PERTAINING TO THE NATURE OF THE REPORTED EVENT COULD BE IDENTIFIED. HOWEVER, BASED ON THE FINDING OF THE MANUFACTURING RECORD EVALUATION (MRE) PERFORMED ON THE INVOLVED ACETABULAR CUP, THE REPORTED EVENT CAN BE CONFIRMED. THIS PRODUCT ISSUE WAS ADDRESSED THROUGH DEPUY SYNTHES QUALITY SYSTEM. THE OVERALL COMPLAINT WAS CONFIRMED BASED ON THE AVAILABLE INFORMATION AND FINDINGS OF THE MRE PERFORMED ON THE INVOLVED IMPLANTS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WAS 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 PERFORMED FOR THE FINISHED DEVICE [121722050 / 9618957] NUMBER, REVEALED THAT THE DEVICE WAS WITHIN THE BOUNDING OF NR-0152452 AND CAPA-010284. THERE IS A CORRELATION BETWEEN THIS NON-CONFORMANCES AND THE FAILURE OF THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOLE ELIMINATOR WENT STRAIGHT THROUGH THE CUP. SURGEON SAID IT DIDN¿T EVEN FEEL THE THREADS COME TOGETHER. COULDN¿T GET THE HOLE ELIMINATOR OUT OF THE PATIENT WITHOUT REMOVING THE CUP. DECIDED TO LEAVE THE HOLE ELIMINATOR IN THE PATIENT. SURGERY WAS DELAYED 3 MINUTES DUE TO THE REPORTED EVENT. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898954 PINNACLE SECTOR II CUP 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS INC US 9618957 10603295009818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown APEX HOLE ELIM POSITIVE STOP| ARTICUL/EZE BALL 28 +1.5 GR| CORAIL AMT COLLAR SIZE 12