BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS

    MDR report key: 11917972 · Received June 1, 2021

    Report

    Report Number
    1038671-2021-00270
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    June 20, 2024
    Report Date
    December 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024299
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) THE MOST LIKELY UNDERLYING CAUSE FOR THE PROSTHESIS WEAR REPORTED MAY HAVE BEEN DUE TO THE POSITION OF THE ACETABULAR CUP, THE USE OF A LATERALIZED LINER, OFF-LABEL USE FROM COMBINING EXACTECH ACETABULAR COMPONENTS WITH ANOTHER MANUFACTURER¿S FEMORAL COMPONENTS, AND/OR PATIENT-RELATED CONDITIONS. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION. IN MARCH, 2021, EXACTECH RECEIVED USER MIR REPORTS FROM BFARM RELATED TO 4 CASES REPORTED BY SURGEONS AT WESTERSEDE HOSPITAL IN GERMANY FOR WEAR OF THE GXL POLYETHYLENE ACETABULA LINER. FURTHER INVESTIGATION WITH THE SURGEONS AT WESTERSTEDE REVEALED THAT THEY HAD 18 PATIENTS (11 UNILATERAL AND 7 BILATERAL), WITH 22 GXL LINERS THAT WERE EXHIBITING SIGNS OF WEAR POTENTIALLY REQUIRING REVISION. THE FOLLOWING COMPLAINTS WERE ENTERED INTO THE GLOBAL COMPLAINT HANDLING SYSTEM TO DOCUMENT THE ANALYSES OF THESE CASES AND VIGILANCE REPORTING REPORT. THE MECHANISMS OF WEAR OF POLYETHYLENE ACETABULAR LINERS ARE CLINICALLY WELL KNOWN IN TOTAL HIP ARTHROPLASTY (THA). ¿CONVENTIONAL¿ UHMWPE HAS GOOD MECHANICAL PROPERTIES BUT IS INHERENTLY PRONE TO WEAR. ¿HIGHLY¿ CROSS LINKING HAS HELPED WITH WEAR BUT INCREASED RISK OF LINER FRACTURES WHEN USED WITH MODERN LOCKING MECHANISMS, LARGE HEADS, THINNER LINERS. CUP MALPOSITION CAN FURTHER LEAD TO EDGE LOADING/EARLY FRACTURE; THUS, SOME COMPANIES CHOSE TO USE ¿MODERATE¿ X LINKING OF THE POLYETHYLENE LINER TO OPTIMIZE FRACTURE RESISTANCE AND IMPROVE WEAR PROPERTIES. EXACTECH TOOK THIS APPROACH WITH THE GXL MODERATELY CROSSLINKED ACETABULAR LINER. IN A WORLDWIDE ANALYSIS OF GXL FAILURES, COMMON CHARACTERISTICS REVEALED THAT COMPONENTS POSITIONED WITH ANTEVERSION AND/OR ABDUCTION (OFTEN SEEN WITH ANTERIOR APPROACHES) RESULT IN EDGE LOADING OF THE GXL LINER. THIS IS COMBINATION WITH LARGE FEMORAL HEADS WITH THINNEST LINER, AND/OR LATERALIZED OR FACE CHANGING LINERS FURTHER INCREASES THE RISK FOR WEAR OF THE GXL LINER ( ~2.OX GREATER AND ~2.5X GREATER, RESPECTIVELY). WESTERSTEDE HOSPITAL PROVIDED 18 SETS OF X-RAYS (11 UNILATERAL HIP/7 BILAT) AND CLINICAL NOTES (DE-IDENTIFIED) FOR ALL REPORTED PATIENTS. DR. SHARAT KUSUMA RECEIVED AND ANALYZED ALL DATA IN COLLABORATION WITH THE WESTERSTEDE SURGEONS. THE FINDINGS WERE AS FOLLOWS: AVERAGE CUP ABDUCTION ON AP XRAY: 51° (RANGE 45 65), 16/25 (64%) HAD EVIDENCE OF EDGE LOADING, 16/25 (64%) WERE THIN INLAYS/LARGE FEMORAL HEADS, 96% OF CUPS WERE WELL FIXED. IN CONCLUSION, IT WAS DETERMINED THAT MOST OF THESE ARE BEST TREATED WITH LINER EXCHANGE; HOWEVER, 2-3 PATIENTS MAY POTENTIALLY REQUIRE REVISION OF ENTIRE CONSTRUCT (INLAY + SHELL) DUE TO LOOSENING OF THE ACETABULAR SHELL. THE SURGEONS AT WESTERSTEDE HOSPITAL HAVE DETERMINE THAT OPTIMAL TREATMENT COURSE FOR THESE PATIENTS IS EXCHANGE OF GXL TO EXACTECH¿S HIGHLY CROSSLINKED XLE LINER. AS THE XLE LINER IS NOT APPROVED FOR USE IN GERMANY, THEY ARE ACTIVELY SEEKING SPECIAL ACCESS APPROVAL/HUMANITARIAN USE EXEMPTION FROM THE GERMANY AUTHORITY, BFARM.

    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-1729-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE FOLLOWING SECTIONS WERE UPDATED: D8. D10 CONCOMITANT DEVICE: (B)(6) 180-01-56 - CROWN CUP,CLUSTER-HOLE GR.56, H6. THE MOST LIKELY UNDERLYING CAUSE FOR THE PROSTHESIS WEAR REPORTED MAY HAVE BEEN DUE TO THE POSITION OF THE ACETABULAR CUP, THE USE OF A LATERALIZED LINER, OFF-LABEL USE FROM COMBINING EXACTECH ACETABULAR COMPONENTS WITH ANOTHER MANUFACTURER¿S FEMORAL COMPONENTS, AND/OR PATIENT-RELATED CONDITIONS. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE MOST LIKELY UNDERLYING CAUSE FOR THE PROSTHESIS WEAR REPORTED MAY HAVE BEEN DUE TO THE POSITION OF THE ACETABULAR CUP, THE USE OF A LATERALIZED LINER, OFF-LABEL USE FROM COMBINING EXACTECH ACETABULAR COMPONENTS WITH ANOTHER MANUFACTURER¿S FEMORAL COMPONENTS, AND/OR PATIENT-RELATED CONDITIONS. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT PRESENTED FOR A CHECK-UP DUE TO OCCASIONAL GROIN PAIN. THE X-RAY AND CT CHECK REVEALED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND CLEAR OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED DURING AN INLAY CHANGE TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY. AS PART OF THE REPLACEMENT SURGERY, IN ADDITION TO THE INLAY EXCHANGE, THE FIXED CUP INTEGRITY WAS DETERMINED AND THE CYSTS IN THE CUP BEARING WERE CURETTED AND SEALED USING HYDROXYAPATITE + CALCIUM) AND THE PROSTHESIS HEAD WAS REPLACED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, IN THE COURSE OF THE CLINICAL-RADIOLOGICAL EXAMINATION OF THE X-RAY IMAGES, ONE POST-OPERATED FOR 3 YEARS IMPLANTATION, A (B)(6) Y/O MALE, INCREASED DECENTRATION OF THE HEAD IN THE INLAY WITHOUT OSTEOLYSIS AS A SIGN OF EXCESSIVE INLAY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808037 NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. N/A UNK 10885862024299

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Disability| R| H SEE H11