BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 11271980 · Received February 3, 2021

    Report

    Report Number
    1818910-2021-02323
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    November 10, 2020
    Report Date
    January 7, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    UDI-DI
    10603295033660
    PMA / PMN Number
    K073570
    Adverse Event
    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. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A DEVICE MANUFACTURING (MRE) REVIEW WILL NOT BE PERFORMED EVEN WHEN PRODUCT/LOT INFORMATION IS KNOWN. PER WI-3430 IT HAS BEEN DETERMINED THAT, FOR THE MOM PLATFORM AND RELATED ALLEGATIONS AN MRE IS NOT REQUIRED. CORRECTED: D1, D2, D4 (CATALOG), D10 . THE PREVIOUS REPORTED MEDICAL DEVICE DLT TS CER HD 12/14 36MM +5.0; PRODUCT CODE: 136536720, LOT NUMBER: 9285561, PROCODE: KWA/K073570 AND DEVICE MANUFACTURE DATE: (B)(6) 2019, ARE BEING RETRACTED AS PER ADDITIONAL INFORMATION THAT THE PRIMARY SURGERY WAS REPORTED AS CALENDAR YEAR (B)(6). THE FEMORAL HEAD ENTERED WAS NOT MANUFACTURED UNTIL (B)(6. THE DEVICE COULD NOT HAVE BEEN IMPLANTED IN (B)(6).

    Additional Manufacturer Narrative · 1

    (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

    CLINICAL ADVERSE EVENT RECEIVED FOR LINER FAILURE - WEAR AND METALLOSIS, ALVAL, KIPPEL TRENAUNAY SYNDROME EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REVISION DUE TO RIGHT HIP PAIN, ADVERSE LOCAL TISSUE REACTION, POLY LINER WEAR AND OSTEOLYSIS OF PROXIMAL FEMUR AND ACETABULUM. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. UPON ENTERING THE JOINT A MASSIVE PSEUDOTUMOR WAS ENCOUNTERED ALONG WITH OSTEOLYSIS. CORROSION WAS NOTED ON THE FEMORAL STEM TRUNNION, POLYWEAR WAS NOTED ON THE LINER. BLOOD LOSS OF 1,000ML WAS NOTED, CELL SAVER WAS UTILIZED AND RETURNED 400ML OF THE PATIENTS OWN BLOOD BACK TO THEM. DATE OF IMPLANT: (B)(6) 2009. DATE OF EVENT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2020 (RIGHT HIP). REVISION OF METAL HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171073 UNKNOWN HIP FEMORAL HEAD ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS KWA DEPUY ORTHOPAEDICS INC US 1365-36-720 9285561 10603295033660

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention ALTRX +4 10D 36IDX54OD.| CORAIL2 LAT COXA VARA SIZE 11.| DLT TS CER HD 12/14 36MM +5.0.| PINNACLE 100 ACET CUP 54MM.| UNKNOWN HIP ACETABULAR LINERS.| ALTRX +4 10D 36IDX54OD| CORAIL2 LAT COXA VARA SIZE 11| DLT TS CER HD 12/14 36MM +5.0| PINNACLE 100 ACET CUP 54MM