BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW LOCK D4.5X36MM

    MDR report key: 11659384 · Received April 13, 2021

    Report

    Report Number
    1818910-2021-07837
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 29, 2021
    Report Date
    March 29, 2021
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    PHX
    UDI-DI
    10603295027850
    PMA / PMN Number
    K120174
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION RECEIVED STATES THAT THERE'S NO OTHER INJURIES TO PATIENT PRIOR TO THE PATIENT¿S FALL WERE REPORTED. THE SURGEON ORDERED A CT SCAN OF THE PATIENT¿S LEFT SHOULDER FOLLOWING THE REVISION SURGERY TO DETERMINE IF THE PATIENT¿S GLENOID COULD SUPPORT A NEW METAGLENE AND GLENOSPHERE WITH BONE GRAFT AS NEEDED AND THE BEST POSITION TO PLACE IT IN.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (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

    IT WAS REPORTED THAT A DEPUY SYNTHES SALES CONSULTANT WAS NOTIFIED PRIOR TO THE CASE BY A SURGEON THAT THE PATIENT HAD FALLEN THE PREVIOUS WEEK AND RE-INJURED THE OPERATIVE SHOULDER. SURGEON ADVISED THAT HE PLANNED TO REVISE THE PATIENT'S INJURED SHOULDER AND TREAT FOR POSSIBLE INFECTION. UPON FURTHER INTRAOPERATIVE EVALUATION, SURGEON DISCOVERED THAT THE METAGLENE, 4 LOCKING SCREWS AND THE GLENOSPHERE HAD ALL BECOME DISLODGED FROM THE PATIENT'S GLENOID. SURGEON WAS ABLE TO EXTRACT ALL OF THESE IMPLANTS AS ON UNIT COMPLETELY PUT TOGETHER AND UNDAMAGED. AT THIS POINT, SURGEON CHECKED THE HUMERAL STEM AND EPIPHYSIS WAS DETERMINED THAT THOSE IMPLANTS REMAINED WELL FIXED AND UNDAMAGED. SURGEON REPLACED THE HUMERAL CUP POLY AND FORMED AN ANTIBIOTIC CEMENT SPACER TO SERVE AS A TEMPORARY FIT PROSTHESIS WHILE THE PATIENT'S INFECTION WILL BE TREATED. DUE TO QUESTIONS ABOUT THE STABILITY AND HEALTH OF THE PATIENT'S GLENOID, SURGEON ASKED FOR ASSISTANCE FROM THE DEPUY SYNTHES TRUMATCH SHOULDER SOLUTIONS TEAM TO EVALUATE OPTIONS AND RECOMMENDATIONS FOR THE PATIENT'S GLENOID FOLLOWING TREATMENT OF THE INFECTION. DOI: (B)(6) 2017, DOR: (B)(6) 2021, LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553149 DXTEND SCREW LOCK D4.5X36MM DELTA XTEND IMPLANTS : SCREWS PHX DEPUY IRELAND 9616671 130790036 5297483 10603295027850

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention DXTEND GLENOSPHERE ECC D42MM| DXTEND METAGLENE| DXTEND SCREW LOCK D4.5X24MM| DXTEND SCREW LOCK D4.5X24MM| DXTEND SCREW LOCK D4.5X36MM| DXTEND SCREW LOCK D4.5X36MM| DXTEND STAND PE CUP D42 +9MM