BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALT HA S CLR STD SZ 8

    MDR report key: 20450507 · Received October 15, 2024

    Report

    Report Number
    1038671-2024-03980
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    October 2, 2024
    Report Date
    December 3, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    MEH
    UDI-DI
    10885862321107
    PMA / PMN Number
    K162732
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANTS: 6764138 01-030-01-0862 - ALT CUP CLSTR G8 SZ 62 A329918 01-030-40-0840 - ALT XLE LNR NTRL G8 40 A443579 170-40-93 - BIOLOX DELTA FEMORAL HEAD 40MM OD, -3.5MM S206138 180-65-30 - ALTEON 6.5MM SCREW, 30MM.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE INITIAL PROCEDURE WAS PERFORMED THROUGH AN ANTERIOR APPROACH. THE REVISION PROCEDURE WAS PERFORMED THROUGH A POSTERIOR LATERAL APPROACH. CORRECTION: H6.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY (THA) PERFORMED. POSTOPERATIVELY, IN RECOVERY, X-RAYS SHOWED THE FEMORAL STEM COMPONENT EXITING THROUGH THE POSTERIOR FEMORAL CANAL WALL. THE STEM WAS NOT IN POSITION. THE PATIENT WAS SCHEDULED FOR A REVISION THA AND FEMORAL STEM REMOVAL AND REIMPLANTATION OF A MONOBLOCK FEMORAL HIP STEM. THE PATIENT WAS REVISED AND THE FEMORAL HEAD AND STEM WERE REMOVED AND A MONOBLOCK STEM AND FEMORAL HEAD WERE IMPLANTED AND CONFIRMED ON X-RAY INTRAOPERATIVELY. THERE WAS NO REPORTED BREAKAGE OF A DEVICE AND 15-30 MINUTE DELAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295019 ALT HA S CLR STD SZ 8 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH EXACTECH, INC. 10885862321107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11.