BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTEON

    MDR report key: 10131330 · Received June 8, 2020

    Report

    Report Number
    1038671-2020-00299
    Event Type
    Injury
    Date Received
    June 8, 2020
    Date of Event
    May 22, 2020
    Report Date
    August 18, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    MEH
    UDI-DI
    10885862321824
    PMA / PMN Number
    K162732
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION NOTED IN THE REVISION REPORTED WAS MOST LIKELY THE RESULT OF A BONE FRACTURE WHICH SUBSEQUENTLY LED TO SUBSIDENCE OF THE FEMORAL COMPONENT. THE BONE FRACTURE MAY HAVE BEEN SECONDARY TO POOR BONE QUALITY, AN INTRA-OPERATIVE FRACTURE THAT WENT UNNOTICED, OR A COMBINATION OF THE TWO, BUT CANNOT BE CONCLUSIVELY DETERMINED FROM THE INFORMATION PROVIDED. THE COMPONENTS WERE ONLY IMPLANTED FOR 11 DAYS BEFORE THE STEM SUBSIDED AND PATIENT WAS SUBSEQUENTLY REVISED. (D11) CONCOMITANT DEVICE: (CN: 170-36-00, SN: (B)(6) - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM (CN: 01-030-01-0450, SN: (B)(6) - ALT CUP CLSTR G4 SZ 50 (CN: 180-65-25, SN: (B)(6) - ALTEON 6.5MM SCREW, 25MM (CN: 180-65-30, SN: (B)(6) - ALTEON 6.5MM SCREW, 30MM (CN: 01-030-40-0436, SN: (B)(6) - ALT XLE LNR NTRL G4 36 NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A4 A5, B6 THE FOLLOWING SECTION(S) HAVE ADDITIONAL INFO; G4, G5, G7, H1, H2, H3, AND H7.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: (CN: 170-36-00, SN: (B)(4)) - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM, (CN: 01-030-01-0450, SN: (B)(4)) - ALT CUP CLSTR G4 SZ 50, (CN: 180-65-25, SN: (B)(4)) - ALTEON 6.5MM SCREW, 25MM, (CN: 180-65-30, SN: (B)(4)) - ALTEON 6.5MM SCREW, 30MM, (CN: 01-030-40-0436, SN: (B)(4)) - ALT XLE LNR NTRL G4 36.

    Description of Event or Problem · 1

    AS REPORTED, A RIGHT PRIMARY ANTERIOR TOTAL HIP WAS PERFORMED ON A (B)(6) FEMALE PATIENT. APPROXIMATELY 11 DAYS POSTOP, DURING PHYSICAL THERAPY, THE PATIENT EXPERIENCED SHARP PAIN AND WAS ADMITTED TO THE HOSPITAL, THE STEM HAS SUBSIDED, AND THE FEMUR POSSIBLY HAS FRACTURED. REVISION OF THE FEMUR IS SCHEDULED FOR NEXT WEEK. NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593614 ALTEON ALTEON HA S NOCLR STD SZ 5 MEH EXACTECH, INC. 190-20-05 10885862321824

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O