BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19390401 · Received May 24, 2024

    Report

    Report Number
    1038671-2024-01463
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    April 22, 2024
    Report Date
    May 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022240
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 3661308 188-01-12 - WEDGE PLASMA X/O SZ 12, 3887150 180-01-60 - NV CROWN CUP CLSTR HOLE 60MM GROUP 4, 3976793 188-01-12 - WEDGE PLASMA X/O SZ 12, 4026248 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM, 4026255 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM, 4056971 180-01-60 - NV CROWN CUP CLSTR HOLE 60MM GROUP 4, 4121163 180-65-25 - ALTEON 6.5MM SCREW, 25MM, 4121261 180-65-25 - ALTEON 6.5MM SCREW, 25MM, 4121754 101-05-30 - 3.2MM DRILL BIT30MM 1PK. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-1729-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS THE CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 103 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BILATERAL HIP PAIN, AND PERIPROSTHETIC OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300186 NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862022240

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R SEE H10