BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCS GXL LINER 5/15 DEG 5052X28

    MDR report key: 16775699 · Received April 20, 2023

    Report

    Report Number
    1038671-2023-00760
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 10, 2015
    Report Date
    December 12, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862013507
    PMA / PMN Number
    K051556
    Removal / Correction Number
    Z-1728-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 1021635 650-00-10 - OPTECURE 10CC RT. 1240193 100-28-05 - COCR FEMORAL HEAD 28MM +5MM NECK.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS - BASED ON AVAILABLE INFORMATION, THE REVISION WAS LIKELY THE RESULT OF A COMBINATION OF THE RISK FACTORS SPECIFIED IN HHE2020-09-11-02 INCLUDING BUT NOT LIMITED TO SIGNIFICANT EDGE LOADING OF THE FEMORAL HEAD ON THE ACETABULAR LINER, IMPLANT POSITIONING, AND PATIENT FACTORS, WHICH LED TO WEAR OF THE ACETABULAR LINER AND PROXIMAL MIGRATION OF THE FEMORAL HEAD. INITIAL SUBMISSION: ALL FIELDS IN SECTION F SHOULD BE BLANK, THIS IS AN MANUFACTURER'S REPORT.

    Additional Manufacturer Narrative · 0

    H3: BASED ON AVAILABLE INFORMATION, THE REVISION INVOLVED IN THE CASE MAY HAVE BEEN THE RESULT OF A COMBINATION OF THE RISK FACTORS SPECIFIED IN THE HHE INCLUDING BUT NOT LIMITED TO USE ERROR, IMPLANT POSITIONING, AND/OR PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES, RADIOGRAPHS, PHOTOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    PER A REPORT FROM THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT HIP REPLACEMENT ON (B)(6) 2008. APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A HIP REVISION ON (B)(6) 2015 DUE TO SUFFERING FROM SYMPTOMS ASSOCIATED WITH EXCESSIVE WEAR OF THE GXL, INCLUDING, BUT NOT LIMITED TO INSTABILITY, PAIN AND LACK OF MOBILITY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: REVISION OPERATIVE REPORT OF (B)(6) 2015- POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL HIP ARTHROPLASTY WITH EXTENSIVE POLYETHYLENE WEAR, AND MASSIVE PELVIC OSTEOLYSIS. PROCEDURE: PATIENT PRESENTED WITH ACUTE DISLOCATION WHICH WAS RELATED TO HIP INSTABILITY FROM POLYETHYLENE WEAR. THERE WAS A SIGNIFICANT ECCENTRICITY OF THE POLYETHYLENE WITH RISK FOR WEAR THROUGH. IN THE JOINT, THERE WAS A SMALL AMOUNT OF SYNOVIAL FLUID AND A LARGE AMOUNT OF SYNOVITIS AND CHANGES FROM HER OSTEOLYSIS. THE SOCKET WAS WELL FIXED AND IN QUITE GOOD POSITION. CONFIRM ECCENTRIC WEAR OF THE SOCKET WITH SIGNIFICANT SUPERIOR WEAR; BASED ON THE INSCRIPTION ON THE RIM THAT THE LINER WAS INDEED GXL XLINKED POLYETHYLENE - REMOVAL OF THE SOCKET. THERE IS POSTERIOR WALL DEFICIENCY AND WITH THE PLATE IS EXPOSED POSTERIORLY, THERE ARE A VERY LARGE CYSTIC OSTEOLYTIC DEFECTS IN THE ISCHIAL TUBEROSITY AS WELL AS THE ILEUM. THERE WAS NO DISCONTINUITY AND THERE WAS MASSIVE BONE LOSS. IDENTIFIED 3 SCREWS THAT WERE IMPINGING ON THE SOCKET, REMOVED THIS FROM AROUND THE PELVIS AND THE PLATE; PROMINENT TO THE SOCKET BUT THIS COULD NOT BE REMOVED WITHOUT SIGNIFICANT DESTRUCTION OF THE REMAINING POSTERIOR WALL; THIS WAS LEFT. REMOVED 52 MM SOCKET. THE REMAINDER OF THE SOCKET HAD BONE DEFECTS FROM THE OSTEOLYSIS. PLACED THE BONE GRAFT, FINGER PACKING INTO THE DEFECTS AND REVERSE REAMED THEM SEQUENTIALLY UNTIL ALL WERE FILLED. DEVICES WERE TRIALED AND THEN IMPLANTED. BULKY DRESSING WAS APPLIED, AND THE PATIENT IS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION, AFTER REVERSAL OF ANESTHESIA, NO COMPLICATIONS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558827 MCS GXL LINER 5/15 DEG 5052X28 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. MCS GXL LINER 5/15 DEG 5052X28 UNK 10885862013507

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention