BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GXL NUETRAL LINER, G0 28MM ID

    MDR report key: 18912415 · Received March 15, 2024

    Report

    Report Number
    1038671-2024-00521
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    February 15, 2024
    Report Date
    January 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022059
    PMA / PMN Number
    K100269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS - 28+0 COCR HEAD - 20MM BONE SCREW. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-1731-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. D10 CONCOMITANT DEVICES: 4317578 180-65-20 - ALTEON 6.5 MM SCREW, 20 MM; 4740859 142-28-00 - COCR FEM HEAD 28 MM +0 OFFSET 12/14; 4772402 180-01-46 - CUP, CLUSTER-HOLE, 46 MM GROUP 0; 4793028 164-13-10 - NOVATION ELEMENT RO S/O COL SZ 10". BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED IN INCIDENT MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR/OSTEOLYSIS: COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND THINNEST AVAILABLE ACETABULAR LINER WAS USED. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR AND PAIN IS A COMBINATION OF THE RISK FACTORS SUCH AS USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL). THE PROSTHESIS WEAR WAS ABLE TO BE CONFIRMED FROM THE PROVIDED RADIOGRAPH. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    H3: BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR/OSTEOLYSIS AS SPECIFIED IN THE HHE: COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND THINNEST AVAILABLE ACETABULAR LINER WAS USED. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR AND PAIN IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN THE HHE. THE PROSTHESIS WEAR WAS ABLE TO BE CONFIRMED FROM THE PROVIDED RADIOGRAPH. CORRECTION: H6 PROBLEM CODE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT THA, THE 72 Y/O FEMALE PATIENT WAS BROUGHT BACK FOR LEFT HIP PAIN. THE FEMUR WAS DISLOCATED, FEMORAL HEAD REMOVED, STEM WAS WELL FIXED. ATTENTION TURNED TO THE CUP. THE LINER WAS REMOVED WITH THE USE OF A BONE SCREW. THE ACETABULAR SCREW WAS REMOVED, CUP CHECKED AND FOUND TO BE WELL FIXED. THE PATIENT RECEIVED A GROUP 0 XLE LIPPED LINER WITH A 28 + 3.5 HEAD. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS RECEIVED. SALES REP WAS UNABLE TO OBTAIN PHOTOS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO PATIENT REQUESTED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535276 GXL NUETRAL LINER, G0 28MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. N/A UNK 10885862022059

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization| R SEE H11