BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 32MM +5

    MDR report key: 12353104 · Received August 23, 2021

    Report

    Report Number
    1818910-2021-18329
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    July 27, 2021
    Report Date
    July 27, 2021
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    UDI-DI
    10603295033479
    PMA / PMN Number
    K073570
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 THE PATIENT HAD PRIMARY THA DONE YEARS AGO. ON (B)(6) 21, FOR THE REASON OF MULTIPLE DISLOCATIONS, PATIENT RECEIVED A CONSTRAINED LINER FROM A DIFFERENT MANUFACTURE ALONG W/A DS HEAD EXCHANGE ON THE IMPLANTED CORAIL STEM. (DER WAS FILLED) RECENTLY, THE PATIENT FELL. POST THAT EVENT, IT WAS NOTED THAT THE RING FROM THE CONSTRAINED LINER (DIFFERENT MANUFACTURE) HAD BECOME DISLODGED & WAS SITTING ON NECK OF STEM. SURGEON DECIDED TO REVISE THE CUP TO A DS MH GRIPTION SHELL ALONG W/A PINNACLE DM LINER & ANOTHER DS TS CERAMIC HEAD LINER. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021, LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249958 DLT TS CER HD 12/14 32MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS KWA DEPUY INTERNATIONAL LTD - 8010379 1365-32-720 9741120 10603295033479

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DLT TS CER HD 12/14 32MM +5.| UNK HIP FEMORAL STEM CORAIL.| DLT TS CER HD 12/14 32MM +5| UNK HIP FEMORAL STEM CORAIL