BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALT XLE LNR NTRL G6 36

    MDR report key: 19431977 · Received May 30, 2024

    Report

    Report Number
    1038671-2024-01626
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 13, 2024
    Report Date
    December 27, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    PMA / PMN Number
    K182502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF FRACTURE OF THE ACETABULAR LINER LOCKING FEATURE WHICH RESULTED IN ITS DISASSEMBLY FROM THE CUP, AND LIKELY CONTRIBUTED TO THE OBSERVED WEAR PATTERN. THE REASON FOR THE FRACTURE COULD NOT BE CONFIRMED SINCE THE PIECE WAS NOT RETURNED FOR EVALUATION, BUT MAY BE RELATED TO INCOMPLETE SEATING OF THE LINER AND/OR THE FEMORAL HEAD LEVERING OUT THE LINER. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 6803671 (B)(6) - ALT CUP CLSTR G6 SZ 54 6911731 170-36-07 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +7MM S005606 (B)(6)- ALTEON 6.5MM SCREW, 30MM S281569 (B)(6)- ALTEON 6.5MM SCREW, 30MM 6071656 (B)(6) - ALT HA S CLR STD SZ 11 32135-38H-17 - 17-4 FLEX DRILL M 3.2X38 LENKBAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 76 Y/O MALE PATIENT'S RIGHT HIP WAS REVISED 2 YEARS 8 MONTHS POST OP. THE ACETABULAR LINER DISASSOCIATED FROM THE CUP. SURGEON REIMPLANTED A 40MM NEUTRAL LINER AND A +7 OPTION 40 HEAD. PATIENT REVISED TO EXACTECH DEVICES: 40 MM NEUTRAL LINER WAS TEMPLATED AND A + 7 40MM OPTION HEAD. REPORTED EVENT IS RELATED TO BREAKAGE OF DEVICE. PARTS, PIECES AND/OR FRAGMENTS WERE REMOVED FROM THE PATIENT: THE DOME HOLE CENTRAL LOCKING MECHANISM WAS SHEARED OFF AND WAS REMOVED. THAT WAS THE ONLY FRAGMENT. NO PARTS, PIECES OR FRAGMENTS FELL INTO PATIENT WOUND. THERE WAS NO SURGICAL DELAY/PROLONGATION AS A RESULT OF REPORTED EVENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400243 ALT XLE LNR NTRL G6 36 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention SEE H10.