BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPILOT THA REAMER SHANK MPR HARRIS

    MDR report key: 11745902 · Received April 29, 2021

    Report

    Report Number
    9610612-2021-00404
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    June 24, 2020
    Report Date
    April 29, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: IN THE LIGHT OF THE SMALL AMOUNT OF INFORMATION RECEIVED AND DUE TO THE CIRCUMSTANCE THAT WE DID NOT RECEIVE THE COMPLAINED DEVICES FOR INVESTIGATION, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE MENTIONED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FS960R - ORTHOPILOT THA REAMER SHANK MPR HARRIS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE REAMER INSTRUMENT WAS DAMAGED DURING THE TOTAL HIP REPLACEMENT (THR) SURGERY. IT WAS NOT FIXED AND THUS MIGRATED/WANDERED. THIS CAUSED THE ACETABULAR CUP PORTION OF THE ACETABULUM TO BE REAMED MORE THAN PLANNED. ALTHOUGH NH548T WAS IMPLANTED FIRST, IT WAS REPLACED WITH NT550T BECAUSE IT WAS NOT FIXED. FINALLY, IT WAS ALSO NOT FIXED, SO ALL IMPLANTS WERE REMOVED. PUBIS FRATURE OCCURRED DUE TO THE OPERATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. A MULTI-HOLE IMPLANT FROM ANOTHER MANUFACTURER WAS THEN USED. ADDITIONAL INFORMATION WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS FS974 - GLOVES PROTECTION F/FS959R/FS960R/FS961R - BATCH UNKNOWN. NH550T - PLASMACUP DC SIZE 50MM - 52521295. NH548T - PLASMACUP DC SIZE 48MM - 52543977. NH522D - DC BIOLOX DELTA INSERT 32MM 48/50 SYM. - 52529914.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640239 ORTHOPILOT THA REAMER SHANK MPR HARRIS HIP ENDOPROSTHETICS HAW AESCULAP AG FS960R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R