BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LPS DSTL FEM TRL LO PROFILE RT

    MDR report key: 12221109 · Received July 23, 2021

    Report

    Report Number
    1818910-2021-15953
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    July 7, 2021
    Report Date
    July 7, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295157830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE WAS UNABLE TO REPLICATE THE REPORTED EVENT. HOWEVER OFF LABEL USE WAS IDENTIFIED. THE INVESTIGATION FOUND NO EVIDENCE OF PRODUCT MALFUNCTION OR PRODUCT ERROR AND THE NEED FOR CORRECTIVE ACTION WAS NOT ESTABLISHED. 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). WHERE THE PRODUCT AND LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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. ADDED: B5 AND H6 (DEVICE). 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

    QUESTION: 1. PLEASE CLARIFY WHAT YOU MEAN BY DAMAGE? IS IT CRACKED? BENT? STRIPPED OR ETC? 2. THE DER IS MARKED "ALL PARTS WERE RETRIEVED". FOR PIECES BEING RETRIEVED FROM PATIENT. PLEASE VERIFY IF THIS WAS MARKED BY MISTAKE OR THE INSTRUMENT BROKE AND WAS LEFT IN THE PATIENT? ANSWERS FOR YOUR QUESTION: 1. THE INNER PIECE OF THE FEMUR, WHERE THE HINGE PIN SLIDES THROUGH HAD BEEN DEFORMED IN SOME WAY. THE PIN WOULD NOT SLIDE THROUGH. 2. THE INITIAL TRIALS WERE NOT BROKEN INTO PIECES. BY SAYING THAT ALL PARTS WERE RETRIEVED. I AM SAYING, THAT ALL THE DAMAGED TRIALS WERE RECEIVED. AND SENT TO OUR CINCINNATI OFFICE. NOTHING WAS BROKEN OFF INTO MULTIPLE PIECES.

    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

    IT WAS REPORTED THAT ON (B)(6) 2021 SURGEON WAS PUTTING AN LPS DISTAL FEMUR TRAIL TOGETHER. HE USED A X-SM RIGHT DISTAL FEMUR TRIAL AND A X-SM HINGE PIN AND NOTICED THAT THE HINGE PIN WAS HAVING A DIFFICULT TIME PASSING THROUGH THE FEMUR. AFTER FURTHER INSPECTION AFTER THE CASE, BOTH THE HINGE PIN AND INNER PART OF THE FEMUR ARE DAMAGED AND NEED TO BE REPLACED. THERE WERE NO BROKEN PIECES AND ALL COMPONENTS WERE FULLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116553 LPS DSTL FEM TRL LO PROFILE RT HIP INSTRUMENTS : FEMORAL TRIALS HWT DEPUY ORTHOPAEDICS INC US 2987-14-105 AF1399337 10603295157830

    Patients

    Seq Age Sex Outcome Treatment
    1