BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH GXL 15DEG LINER 28MM SZ H

    MDR report key: 19011095 · Received April 1, 2024

    Report

    Report Number
    1038671-2024-00703
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    April 24, 2011
    Report Date
    April 1, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862023100
    PMA / PMN Number
    K051556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: PENDING INVESTIGATION. THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE. CONCOMITANTS: 829218, 116-01-04 - ACUMATCH C-SERIES 12/14 SZ 4. 904883, 120-65-25 - BONE SCREW 6.5MM DIA X 25MM LONG. 789828, 120-65-45 - BONE SCREW 6.5MM DIA X 45MM LONG. 378274, 124-01-56 - ACUMATCH CLUSTER CUP POROUS BEAD W/HA 56MM. 4661203, 13A2101 - CEMEX SYSTEM FAST GENTA 70G. 802570, 142-28-00 - COCR FEM HEAD 28MM +0 OFFSET 12/14. 6060114, 620-00-01 - ACCELERATE PRP KIT 2 SPIN. F92F, KIT-01 - CEMEX PREP KIT. 756863, PC-17 - STEM CENTRALIZER 17MM.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2011 APPROXIMATELY 4 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361126 ACUMATCH GXL 15DEG LINER 28MM SZ H PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO EXACTECH, INC. 10885862023100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention