BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19560506 · Received June 18, 2024

    Report

    Report Number
    1038671-2024-01966
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    April 4, 2023
    Report Date
    February 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862021144
    PMA / PMN Number
    K993082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED: MFG #1038671-2023-02612 REPORT 1 OF 3. REPORT 3 OF 3. ADDITIONAL MANUFACTURER NARRATIVE- REPORT 2 OF 3. D10. CONCOMITANTS: 130-36-54 - NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS 122-65-20 - 6.5MM ACETABULAR BONE SCREW 20MM 3852475 180-01-60 - NV CROWN CUP CLSTR HOLE 60MM GROUP 4 3887169. H3. INVESTIGATION RESULTS- THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, AND LOOSENING OF THE BONE SCREW, AS STATED IN THE OPERATIVE NOTES. ADDITIONAL CONTRIBUTING FACTORS TO THE REPORTED FAILURES MAY HAVE BEEN THE RESULT OF A COMBINATION OF RISK FACTORS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED AT THE TIME OF THIS EVALUATION. THE OCCURRENCE RATES ARE ¿VERY LOW,¿ AND THE IDENTIFIED RISKS RELATED TO THESE FAILURES ARE LISTED IN THE PRODUCT LABELING AND ARE WITHIN THE LEVEL ASSESSED IN THE CURRENT RISK MANAGEMENT FILES. THE DEVICE HISTORY RECORDS FOR THE BONE SCREWS - ALL PARTS WERE ACCEPTED WITH CONFORMANCE TO THE DEVICE SPECIFICATIONS. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE MANUFACTURING-RELATED. IT IS UNCLEAR IF THE 20MM OR THE 30MM BONE SCREW WAS FOUND TO BE LOOSE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-02612, 1038671-2024-01968. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION REPORTED IS PROSTHESIS WEAR AND LOOSENING AND A COMBINATION OF 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). HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY."

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT THEN APPROXIMATELY 8 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. REVISION OP REPORT - DIAGNOSIS: FAILED RIGHT HIP. THE PATIENT WAS REVISED TO COMPETITOR'S DEVICES. THE PATIENT HAD A VERY LARGE OSTEOLYTIC DEFECT ABOVE THE CUP THAT REQUIRED CREATING A BONY WINDOW, CURETTAGE, RONGEURING, AND BONE GRAFTING AND THEN REPLACING THE BONY WINDOW. THE SURGEON REMOVED SOME GREEN NONABSORBABLE SUTURE IN THE CAPSULE. THERE WAS ABUNDANT EVIDENCE OF VILLONODULAR ADVERSE LOCAL TISSUE REACTION FOUND. THERE WAS SOME ADVERSE LOCAL TISSUE REACTION AROUND THE STEM WITH A SMALL AMOUNT OF OSTEOLYSIS BENEATH THE CALCAR AND AROUND THE STEM. THE STEM WAS WELL FIXED AND SOLID. THE LINER HAD WEAR SUPERIORLY. THE MORE ANTERIOR SCREW WAS LOOSE FROM THE OSTEOLYTIC DEFECT AND ENCOMPASSED THE POSTERIOR SCREW WELL. A STERILE BANDAGE WAS APPLIED. THERE IS NO SURGICAL DISPOSITION PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. PRODUCT: 122-65-20 - 6.5MM ACETABULAR BONE SCREW 20MM SERIAL: (B)(6) 510K: K993082 UDI: (B)(4) PRODUCT CODE: JDI LPH CONCOMITANTS: 130-36-54 - NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS 122-65-30 - 6.5MM ACETABULAR BONE SCREW 30MM 3870276 180-01-60 - NV CROWN CUP CLSTR HOLE 60MM GROUP 4 3887169 PRODUCT: 122-65-30 - 6.5MM ACETABULAR BONE SCREW 30MM SERIAL: (B)(6) 510K: K993082 UDI: (B)(4) PRODUCT CODE: JDI LPH CONCOMITANTS: 130-36-54 - NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS 122-65-20 - 6.5MM ACETABULAR BONE SCREW 20MM 3852475 180-01-60 - NV CROWN CUP CLSTR HOLE 60MM GROUP 4 3887169.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338554 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862021144

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| H SEE H10.