BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED LINER INSERTER IMPACTOR TIP 22MM

    MDR report key: 14982980 · Received July 11, 2022

    Report

    Report Number
    0002249697-2022-00995
    Event Type
    Injury
    Date Received
    July 11, 2022
    Date of Event
    June 6, 2022
    Report Date
    July 11, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HWC
    UDI-DI
    07613327244861
    PMA / PMN Number
    K151264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PRIMARY TOTAL HIP REPLACEMENT (EXETER/TRIDENT) COMPLETED. PRIMARY REVISED DUE TO STABILITY. LINER EXCHANGED FROM TRIDENT 36D 0DG LINER TO TRIDENT 22.2D CONSTRAINED LINER USING 22.2MM CONSTRAINED IMPACTOR. DURING THE REVISION CASE, PART OF THE CONSTRAINED LINER IMPACTOR FLANGE BROKE. FOLLOWING THE CASE, AN REPLACEMENT WAS LODGED TO REPLACE THE INSTRUMENT. LATER THEATRE STAFF EMAILED A BOOKING REQUEST FOR "DEBRIDEMENT OF SEROMA, EXETER DAIR BACKUP" FOR THE AFOREMENTIONED PATIENT. THE SEROMA DEBRIDEMENT PROCEEDED. THEATRE STAFF ALERTED STRYKER PERSONNEL THAT DURING THE SEROMA DEBRIDEMENT, A PIECE OF PLASTIC DEBRIS WAS REMOVED FROM THE PATIENTS HIP, ALLEGED TO HAVE ARISEN FROM THE CONSTRAINED LINER IMPACTOR USED AND BROKEN DURING THE PREVIOUS CASE . THIS IS FOR THE "DEBRIDEMENT OF SEROMA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015365 CONSTRAINED LINER INSERTER IMPACTOR TIP 22MM SCREW, FIXATION, BONE HWC STRYKER ORTHOPAEDICS-MAHWAH 2199-2022 UNKNOWN 07613327244861

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R