BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS

    MDR report key: 18426243 · Received January 2, 2024

    Report

    Report Number
    1038671-2024-00003
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    June 14, 2023
    Report Date
    April 15, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862022240
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4655572 101-05-30 - 3.2MM DRILL BIT30MM 1PK, 4817193 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM, 4120988 180-65-20 - ALTEON 6.5MM SCREW, 20MM, 4946927 180-65-30 - ALTEON 6.5MM SCREW, 30MM, 4868525 186-01-60 - INTEGRIP CC, CLUSTER 60MM, G4, 3661700 188-00-12 - WEDGE PLASMA S/O SZ 12. PENDING INVESTIGATION

    Additional Manufacturer Narrative · 0

    THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE EARLY PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE NOT CONFIRMED WITH THE INFORMATION PROVIDED; DEVICES WERE NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023, FINDINGS: THERE WAS EXTENSIVE SYNOVITIS AND BROWNISH DISCOLORATION OF THE ARTICULAR SOFT TISSUES. THERE WAS A LARGE JOINT EFFUSION. FEMORAL COMPONENT WAS WELL FIXED WITHOUT SIGNS OF WEAR OR LOOSENING. THE ACETABULAR COMPONENT HAD ECCENTRIC POLYETHYLENE WEAR THAT INVOLVED ALL THE WAY OUT TO THE RIM OF THE ACETABULUM. THE FEMORAL HEAD DID NOT SIT CONGRUENTLY WITH AND THIS DUE TO THE WEAR. PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262192 NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO EXACTECH, INC. UNK 10885862022240
    581174 NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO EXACTECH, INC. UNK 10885862022240

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention SEE H10