BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD

    MDR report key: 11979361 · Received June 10, 2021

    Report

    Report Number
    1038671-2021-00289
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 18, 2021
    Report Date
    October 12, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) THE EVALUATION NOTED THAT REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF TRAUMA AND PROSTHESIS WEAR. HOWEVER, THE POTENTIAL CONTRIBUTIONS FROM PRIOR PROSTHESIS WEAR, ALIGNMENT OF THE CUP AND PARTICLE-INDUCED OSTEOLYSIS TO THE ULTIMATE MALPOSITIONING OF THE CUP, SUBSEQUENT IMPINGEMENT WITH THE FEMORAL NECK, AND REPORTED DAMAGE TO THE IMPLANTS FOLLOWING THE TRAUMATIC EVENT CANNOT BE DETERMINED FROM THE PROVIDED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "LOOSENING" IS ASSOCIATED WITH WEAKENED INTEGRATION OF THE DEVICE AT THE BONE-IMPLANT INTERFACE DUE TO LOSS OF FIBROUS AND/OR BONY TISSUE AND LEADING TO COMPROMISED ANCHORAGE OF THE DEVICE. SECTION B2: DISABILITY OR PERMANENT DAMAGE (NO DISABILITY OR DAMAGED TO THE PATIENT).

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS B5, G3, G7 AND H2 HAVE BEEN UPDATED ACCORDINGLY. SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE ARE NO IMAGES OF THE EXPLANTS. THERE WERE 10-14 DAYS BETWEEN THE MVA AND THE REVISION SURGERY. THE PATIENT WAS PLANNING ON HAVING THE HIP REVISED PRIOR TO THE MVA HOWEVER THE MVA SPEED THINGS UP. MOREOVER, THE SURGEON ATTRIBUTES THE SEVERITY OF THE DAMAGE TO THE ACETABULUM TO THE WEAK BONE STRUCTURE CREATED BY THE OSTEOLYSIS AND POLY DEBRIS FROM THE GXL. PER SALES REP ¿HE BELIEVES THAT THE CUP POSITIONING WAS OK PRIOR TO THE MVA¿.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: GXL LINER, INTERGRIP CLUSTER SHELL. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 7 YEARS POSTOP THE INITIAL IMPLANT, THE SURGEON WAS REVISING THE RIGHT HIP, IT WAS NOTED THAT THIS (B)(6) Y/O FEMALE PATIENT HAD SEVERE OSTEOLYSIS AND WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT (MVA). AFTER THE MVA SHE WAS EXPERIENCING SEVERE PAIN WHICH LED TO THE REVISION. UPON OPENING THE PATIENT UP SURGEON SAW A TREMENDOUS AMOUNT OF OSTEOLYSIS, POLY WEAR, AND SOME OF THE SHELL SEEMED TO HAVE BEEN PEELED OFF. THE JOINT HAD POLY WEAR AND DEBRIS AS WELL AS METAL DEBRIS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871057 FEMORAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. FEMORAL HEAD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention| S