BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS

    MDR report key: 11916902 · Received June 1, 2021

    Report

    Report Number
    1038671-2021-00266
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    April 1, 2021
    Report Date
    December 7, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024275
    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

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G7, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) IN MARCH, 2021, EXACTECH RECEIVED USER MIR REPORTS FROM (B)(6) RELATED TO 4 CASES REPORTED BY SURGEONS AT (B)(6) HOSPITAL IN GERMANY FOR WEAR OF THE GXL POLYETHYLENE ACETABULA LINER. FURTHER INVESTIGATION WITH THE SURGEONS AT (B)(6) 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) (B)(6) HOSPITAL PROVIDED 18 SETS OF X-RAYS (11 UNILATERAL HIP/7 BILAT) AND CLINICAL NOTES (DE-IDENTIFIED) FOR ALL REPORTED PATIENTS. DR. (B)(6) RECEIVED AND ANALYZED ALL DATA IN COLLABORATION WITH THE (B)(6) 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 (B)(6) 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, (B)(6).

    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 PART OF THE CLINICAL-RADIOLOGICAL EXAMINATION OF THE X-RAY IMAGES FOR THIS (B)(6) Y/O FEMALE PATIENT, ONE MADE AN IMPRESSION FOR 6 YEARS IMPLANTATION INCREASED DECENTRATION OF THE HEAD IN THE INLAY AS A SIGN OF EXCESSIVE INLAY WEAR. ALL AVAILABLE INFORMATION RECEIVED AT THIS TIME. DEVICE WILL NOT RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808365 NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS UNK 10885862024275

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Disability| R