BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    MDR report key: 17825068 · Received September 27, 2023

    Report

    Report Number
    1038671-2023-02385
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    August 15, 2023
    Report Date
    October 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207081
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3. INVESTIGATION RESULTS- THE NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS 5236677 WITH SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT'S CONDITION OF PENDING REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THE PATIENT HAD BILATERAL HIP REPLACEMENTS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B4, D4, D6B. CORRECTION: H6.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM 5211619 180-65-20 - ALTEON 6.5MM SCREW, 20MM 4946663 180-65-25 - ALTEON 6.5MM SCREW, 25MM 5365980 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2 5371861 188-00-08 - WEDGE PLASMA S/O SZ 8 5028350 188-00-09 - WEDGE PLASMA S/O SZ 9 5279048. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    HIP WAS DISLOCATED POSTERIOR. STEM WAS STABLE AND WELL FIXED. ABDUCTORS WERE MINIMAL DAMAGE, 20% DAMAGE FROM OSTEOLYSIS. SIGNIFICANT AMOUNT OF DENSE SCAR TISSUE WAS RESECTED FROM THE AROUND THE HIP JOINT. POLY LINER FROM CUP USING DRILL SCREW TECHNIQUE. CUP OUT USED TO REMOVE THE CUP. IT WAS ELECTED TO PLACE A DUAL MOBILITY LINER. THE LINER WAS INSERTED INTO THE CUP AND IMPACTED. IT IS NOTED TO BE WELL SEATED AND LOCKED INTO POSITION. REAL HEAD IMPACTED ONTO THE STEM. HIP WAS REDUCED INTO THE CONSTRAINED CUP. IT WAS VERY STABLE AND DID NOT DISLOCATE OR IMPINGE WITH HIP FLEXION 90 DEGREES AND INTERNAL ROTATION TO 90 DEGREES. PATIENT WAS REVERSED FROM ANESTHESIA AND MOVED ONTO THE HOSPITAL BED WITHOUT DIFFICULTY. PATIENT WAS TAKEN TO PACU IN STABLE CONDITION. CUP WAS REMOVED WITHOUT DIFFICULTY - MINIMAL BONE IN GROWTH. STEM WAS STABLE, WELL FIXED, AND WELL POSITIONED - THEREFORE KEPT THE STEM. VERY STABLE RECONSTRUCTION. MODERATE AMOUNT OF SOFT TISSUE CONSISTENT WITH OSTEOLYSIS. MODERATE AMOUNT OF ACETABULAR BONE DAMAGE DUE TO OSTEOLYSIS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON 25 APR 2018. THE DEVICE HAS NOT BEEN EXPLANTED (LEFT HIP IS PENDING REVISION (B)(6) 2023.)HER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020017 NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS UNK 10885862207081

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention SEE H10