BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA CER INSERT 36ID X 56OD

    MDR report key: 5049562 · Received September 2, 2015

    Report

    Report Number
    1818910-2015-29572
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    MRA
    PMA / PMN Number
    PP070026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: CONCLUSION AND JUSTIFICATION STATUS: SURGEON WAS ATTEMPTING TO IMPLANT ACETABULAR INSERT (1218-81-756) INTO ACETABULAR SHELL (1217-22-056) AS SURGICAL TECHNIQUE GUIDE STATES. INSERT WAS LOADED ONTO PINNACLE ALTERNATE BEARING INSERTER AND WAS LINED UP WITH EMPTY ANTIROTAION DEVICE HOLES. SURGEON DID A LIGHT TAP ON INSERTER HANDLE TO REMOVE INSERT, THEN FOLLOWED WITH PINNACLE STRAIGHT CUP IMPACTOR WITH APPROPRIATE 36MM IMPACTOR TIP LOADED. SURGEON DELIVERED MODERATE BLOWS TO IMPACTOR AND ON THE 4TH HIT THE CERAMIC INSERT SHATTERED ON AN PROXIMATELY 2CM PORTION OF THE UPPER LIP. SHARDS WERE REMOVED FROM THE PATIENT. BOTH THE ACETABULAR INSERT AND THE ACETABULAR SHELL WERE REMOVED AS ONE PIECE. THE REMAINDER OF CERAMIC SHARDS WERE REMOVED AND A NEW ACETABULAR SHELL AND CERAMIC INSERT OF THE SAME SIZE WERE IMPLANTED WITH NO FURTHER PROBLEMS. ALL VISIBLE SHARDS WERE REMOVED WITH FINE TIPPED ADSON HEMOSTAT CLAMPS AND AREA WAS THOROUGHLY IRRIGATED. THE INITIAL REVIEW OF THE INFORMATION MADE AVAILABLE TO THE INVESTIGATION FOUND THE PRODUCT WAS TO SPECIFICATION AT THE TIME OF MANUFACTURING. THIS INFORMATION AND THE RETURNED PRODUCT HAVE BEEN SENT FOR FURTHER INVESTIGATION TO THE CERAMIC SUPPLIER. THE SUPPLIER WILL CARRY OUT FURTHER IN-DEPTH ANALYSIS TO ASSIST IN THE DETERMINATION OF THE ROOT CAUSE. THE INVESTIGATION SHALL BE CLOSED WITH AN INTERIM REPORT AND BE REOPENED WHEN THE SUPPLIERS REPORT IS COMPLETED. THE INVESTIGATION WILL BE CLOSED WITH AN INTERIM REPORT AND WILL BE REOPENED WHEN THE CERAMIC SUPPLIER¿S REPORT IS COMPLETE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). SURGEON WAS ATTEMPTING TO IMPLANT ACETABULAR INSERT (1218-81-756) INTO ACETABULAR SHELL (1217-22-056) AS SURGICAL TECHNIQUE GUIDE STATES. INSERT WAS LOADED ONTO PINNACLE ALTERNATE BEARING INSERTER AND WAS LINED UP WITH EMPTY ANTIROTAION DEVICE HOLES. SURGEON DID A LIGHT TAP ON INSERTER HANDLE TO REMOVE INSERT, THEN FOLLOWED WITH PINNACLE STRAIGHT CUP IMPACTOR WITH APPROPRIATE 36MM IMPACTOR TIP LOADED. SURGEON DELIVERED MODERATE BLOWS TO IMPACTOR AND ON THE 4TH HIT THE CERAMIC INSERT SHATTERED ON AN APPROXIMATELY 2CM PORTION OF THE UPPER LIP. SHARDS WERE REMOVED FROM THE PATIENT. BOTH THE ACETABULAR INSERT AND THE ACETABULAR SHELL WERE REMOVED AS ONE PIECE. THE REMAINDER OF CERAMIC SHARDS WERE REMOVED AND A NEW ACETABULAR SHELL AND CERAMIC INSERT OF THE SAME SIZE WERE IMPLANTED WITH NO FURTHER PROBLEMS. ALL VISIBLE SHARDS WERE REMOVED WITH FINE TIPPED ADSON HEMOSTAT CLAMPS AND AREA WAS THOROUGHLY IRRIGATED. THE INITIAL REVIEW OF THE INFORMATION MADE AVAILABLE TO THE INVESTIGATION FOUND THE PRODUCT WAS TO SPECIFICATION AT THE TIME OF MANUFACTURING. THIS INFORMATION AND THE RETURNED PRODUCT HAVE BEEN SENT FOR FURTHER INVESTIGATION TO THE CERAMIC SUPPLIER. THE SUPPLIER WILL CARRY OUT FURTHER IN-DEPTH ANALYSIS TO ASSIST IN THE DETERMINATION OF THE ROOT CAUSE. THE INVESTIGATION SHALL BE CLOSED WITH AN INTERIM REPORT AND BE REOPENED WHEN THE SUPPLIERS REPORT IS COMPLETED. THE INVESTIGATION WILL BE CLOSED WITH AN INTERIM REPORT AND WILL BE REOPENED WHEN THE CERAMIC SUPPLIER¿S REPORT IS COMPLETED. THE COMPLAINT WAS REOPENED AS THE SUPPLIER REPORT WAS RECEIVED WHICH STATES THE DENSITY, MICROSTRUCTURES, PROTOCOLS AND CERTIFICATES MEET THE REQUIREMENTS AT THE TIME OF PRODUCTION. THE SUPPLIER REPORT SUGGESTS THAT DUE TO THE MISALIGNED POSITION OF THE INSERT IN THE METAL SHELL THIS CAUSED POINT CONTACTS WHICH INITIATED THE FRACTURE. HOWEVER WITHOUT FURTHER INFORMATION THIS CANNOT BE CONFIRMED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION, ENTERED INTO THE COMPLAINTS DATABASES AND MONITORED THROUGH TREND ANALYSIS. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    SURGEON DELIVERED MODERATE BLOWS TO IMPACTOR AND ON THE 4TH HIT THE CERAMIC INSERT SHATTERED ON AN APROXIMATELY 2CM PORTION OF THE UPPER LIP. SHARDS WERE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580816 DELTA CER INSERT 36ID X 56OD HIP ACETABULAR INSERT/LINER MRA DEPUY IRELAND 9616671 8106757

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR