BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 28MM +8.5

    MDR report key: 12439328 · Received September 8, 2021

    Report

    Report Number
    1818910-2021-19634
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    August 18, 2021
    Report Date
    August 18, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033295
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MATERIAL, MANUFACTURING, INSPECTION OR STERILE PROCESSING THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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

    IT WAS REPORTED THAT THE PATIENT'S HIP WAS INFECTED SO HE REMOVED RECLAIM PROXIMAL BODY AND HEAD TO A GIRDLESTONE. THE CUP COMPONENTS WERE REMOVED AS WELL BUT THEY WERE A COMPETITIVE COMPANY¿S IMPLANTS. DR. BROWN CHOICE TO LEAVE THE DISTAL RECLAIM STEM BECAUSE IT WAS WELL FIXED AND DIDN¿T WANT TO RISK FRACTURING PATIENTS FEMUR. STEM THAT WAS LEFT IN WAS REF# 1977-27-240 LOT#110412. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339093 DELTA CER HEAD 12/14 28MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 1365-28-330 9363347 10603295033295

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention DELTA CER HEAD 12/14 28MM +8.5| RECLAIM PRX BDY CONE 20X75| DELTA CER HEAD 12/14 28MM +8.5| RECLAIM PRX BDY CONE 20X75