BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLASSIC BIPOLAR HEAD

    MDR report key: 23149843 · Received September 25, 2025

    Report

    Report Number
    3008544874-2025-00002
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Report Date
    September 23, 2025
    Manufacturer
    TOTAL JOINT ORTHOPEDICS, INC
    Product Code
    KWY
    PMA / PMN Number
    K143113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT AFFECTS THE KLASSIC BIPOLAR HEAD POUCHES THAT ARE USED FOR ALL SIZES OF BIPOLAR HEADS. TOTAL JOINT ORTHOPEDICS IS WORKING WITH BIOPRO TO RESOLVE THIS ISSUE BUT IN THE MEANTIME TOTAL JOINT ORTHOPEDICS HAS RECALLED ALL OF THE BIPOLAR HEADS THAT WERE BOXED AND LABELED WITH TOTAL JOINT ORTHOPEDICS AS THE MANUFACTURER. THE FOLLOWING IS A LIST OF ALL AFFECTED INVENTORY THAT IS BEING RECALLED BY TOTAL JOINT ORTHOPEDICS: PART NUMBERS: DESCRIPTION: GTIN: QTY: 3205.41.022, KLASSIC BIPOLAR HEAD, 41 MM OD, 22 MM HEAD (B)(4), 17. 3205.42.022, KLASSIC BIPOLAR HEAD, 42 MM OD, 22 MM HEAD (B)(4), 21. 3205.43.022, KLASSIC BIPOLAR HEAD, 43 MM OD, 22 MM HEAD (B)(6) 22. 3205.44.028, KLASSIC BIPOLAR HEAD, 44 MM OD, 28 MM HEAD (B)(4), 20. 3205.45.028, KLASSIC BIPOLAR HEAD, 45 MM OD, 28 MM HEAD (B)(4), 21. 3205.46.028, KLASSIC BIPOLAR HEAD, 46 MM OD, 28 MM HEAD (B)(4), 12. 3205.47.028, KLASSIC BIPOLAR HEAD, 47 MM OD, 28 MM HEAD (B)(4), 15. 3205.48.028, KLASSIC BIPOLAR HEAD, 48 MM OD, 28 MM HEAD (B)(4), 24. 3205.49.028, KLASSIC BIPOLAR HEAD, 49 MM OD, 28 MM HEAD (B)(4), 30. 3205.50.028, KLASSIC BIPOLAR HEAD, 50 MM OD, 28 MM HEAD (B)(4), 34. 3205.51.028, KLASSIC BIPOLAR HEAD, 51 MM OD, 28 MM HEAD (B)(4), 36. 3205.52.028, KLASSIC BIPOLAR HEAD, 52 MM OD, 28 MM HEAD (B)(4), 24. 3205.53.028, KLASSIC BIPOLAR HEAD, 53 MM OD, 28 MM HEAD (B)(4), 32. 3205.54.028, KLASSIC BIPOLAR HEAD, 54 MM OD, 28 MM HEAD (B)(4), 42. 3205.55.028, KLASSIC BIPOLAR HEAD, 55 MM OD, 28 MM HEAD (B)(4), 34. 3205.56.028, KLASSIC BIPOLAR HEAD, 56 MM OD, 28 MM HEAD (B)(4), 18. 3205.58.028, KLASSIC BIPOLAR HEAD, 58 MM OD, 28 MM HEAD (B)(4), 22. 3205.60.028, KLASSIC BIPOLAR HEAD, 60 MM OD, 28 MM HEAD (B)(4), 23. THESE PART WILL BE PLACED IN QUARANTINE UNTIL THE INVESTIGATION AND CORRECTIVE ACTION HAVE BEEN COMPLETED.

    Description of Event or Problem · 0

    THE KLASSIC BIPOLAR HEAD IS PACKAGED IN A DOUBLE-PEEL PACK CONFIGURATION, WITH A CLEAN OUTER POUCH AND A STERILE INNER POUCH, AND IS CONTAINED IN A SEALED CARDBOARD BOX. TJO WAS ALERTED BY OUR SUPPLIER/LICENSOR (BIOPRO) TO A POTENTIAL BREACH IN THE STERILE BARRIER SYSTEM TO EXIST DUE TO NON-VISUALLY DETECTIBLE PIN-HOLE DEFECTS IN THE DOUBLE TYVEK POUCH PACKAGING CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2861529 KLASSIC BIPOLAR HEAD BIPOLAR HEAD KWY TOTAL JOINT ORTHOPEDICS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other