BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH A-SERIES

    MDR report key: 8608648 · Received May 14, 2019

    Report

    Report Number
    1038671-2019-00280
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 18, 2019
    Report Date
    July 8, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K993082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H1): THE REVISION REPORTED IN THE EXPERIENCE WAS LIKELY THE RESULT OF OSTEOLYSIS OR PATIENT CONDITIONS, WHICH LED TO "SEVERE BONE LOSS BEHIND THE ACETABULAR SHELL". THE FOLLOWING SECTIONS HAVE ADDITIONAL INFO: B4, G4, G7, AND H1. NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A2, A3, A4, B6, AND B7. (D11) CONCOMITANT DEVICES: 1. CN: 142-36-00, SN (B)(6) - COCR FEMORAL HEAD 36MM, +0 OFFSET 12/14. 2. CN: 120-65-25, SN (B)(6) - BONE SCREW, 6.5MMX25MM . 3. CN: 132-36-29, SN (B)(6) - ACUMATCH GXL 15 DEGREE LINER, 36MM, SIZE J.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: CN: 142-36-00, SN (B)(4) - COCR FEMORAL HEAD 36MM, +0 OFFSET 12/14. CN: 120-65-25, SN (B)(4) - BONE SCREW, 6.5MMX25MM. CN: 132-36-29, SN (B)(4) - ACUMATCH GXL 15 DEGREE LINER, 36MM, SIZE J.

    Description of Event or Problem · 1

    REVISION DUE TO THE PATIENT HAD SEVERE BONE LOSS BEHIND THE ACETABULAR SHELL. THE SURGEON OPENED THE JOINT IN STANDARD FASHION. THE SURGEON DISLOCATED THE HIP. THE SURGEON THEN TOOK A BONE TAMP AND KNOCKED OFF THE IMPLANTED FEMORAL HEAD. THE SURGEON THEN TOOK OUT THE LINER AND CUP. THERE WAS ONE SCREW THAT THE SURGEON REMOVED AS WELL. THE SURGEON THEN REPLACED THE EXPLANTED CUP WITH A STRYKER TRITANIUM CUP AND LINER. THE SURGEON THEN IMPLANTED OUR 36 MM HEAD. THE SURGEON LIKES THE +3.5 HEAD. THE SURGEON THEN REDUCED THE HIP. THE SURGEON THEN CLOSED THE JOINT IN STANDARD FASHION. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. ORIGINAL SURGERY WAS DONE ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402529 ACUMATCH A-SERIES ACUMATCH CLUSTER CUP POROUS COATED 60MM JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10.