BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 AP CHAMF BLK POPUP R.H.SZ4

    MDR report key: 13950749 · Received March 30, 2022

    Report

    Report Number
    1818910-2022-05802
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    January 1, 2022
    Report Date
    March 30, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTZ
    UDI-DI
    10603295246992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. 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 MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PFC SIZE 4 CHAMFER CUTTING BLOCK IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761164 SP2 AP CHAMF BLK POPUP R.H.SZ4 KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES HTZ DEPUY ORTHOPAEDICS INC US 96-6144 10603295246992

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown