BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTEON CUP, CLSTR HOLE G6, SIZE 54MM

    MDR report key: 12342159 · Received August 19, 2021

    Report

    Report Number
    1038671-2021-00399
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    August 2, 2021
    Report Date
    July 15, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862550002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G7, H2 AND H6 HAVE BEEN UPDATED ACCORDINGLY. AS REPORTED, APPROXIMATELY SIX MONTHS POSTOP THE INITIAL LTHA, THIS 79 Y/O MALE PATIENT WAS REVISED DUE TO A PERI PROSTHETIC FRACTURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL POLICY. THESE DEVICES WERE USED FOR TREATMENT, NOT DIAGNOSIS. A KNOWN SURGICAL RISK FOR TOTAL HIP REVISION IS POTENTIAL BONE FRACTURE. AS PART OF THE PREOPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURGERY AND/OR POSTOPERATIVE PERIOD. THE MOST LIKELY CAUSE FOR THE BONE FRACTURE POSSIBLY SURGICAL TECHNIQUE AND PATIENT CONDITIONS AT THE TIME OF IMPLANTATION OF THE TOTAL HIP COMPONENTS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: BIOLOX DELTA FEMORAL HEAD 40MM OD, +7MM (CAT# 170-40-07). CUP (CAT# 01-030-10-0654 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY SIX MONTHS POSTOP THE INITIAL LTHA, THIS (B)(6) MALE PATIENT WAS REVISED DUE TO A PERI PROSTHETIC FRACTURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238151 ALTEON CUP, CLSTR HOLE G6, SIZE 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. ALT XLE LNR EXTCOV G6 40 UNK 10885862550002

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention