BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTEON 6.5MM SCREW, 30MM

    MDR report key: 21078773 · Received January 6, 2025

    Report

    Report Number
    1038671-2025-00074
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    January 30, 2023
    Report Date
    January 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    UDI-DI
    10885862272669
    PMA / PMN Number
    K141797
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2023-02087, 1038671-2025-00073 D10CONCOMITANTS: 170-40-00 - BIOLOX DELTA FEMORAL 40MM OD, +0MM 5314873 180-65-25 - ALTEON 6.5MM SCREW, 25MM 5403711 186-01-58 - INTEGRIP CC, CLUSTER 58MM, G3 5396926 188-00-11 - WEDGE PLASMA S/O SZ 11 4597715 130-40-53 - NV GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS 4191250 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-02087, 1038671-2025-00073 BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED IN INCIDENT MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR: COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE LINER WAS USED, IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION REPORTED IS 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, A PATIENT HAD RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2018. THEY UNDERWENT RIGHT HIP REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 4 YEARS 8 MONTHS AFTER THEIR INITIAL IMPLANTATION. THE PATIENT CLAIMS TO HAVE SUFFERED FROM EXTREME PAIN, LIMPING, INSTABILITY AND A REVISION SURGERY AS A RESULT OF THIS DEVICE. PATIENT EXPERIENCED PROTHESIS WEAR, LOOSENING, SYNOVITIS, FAILURE OF IMPLANT, OSTEOLYSIS, JOINT LAXITY AND PAIN. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. PER THE REVISION OPERATIVE NOTES, "THE STEM WAS WELL FIXED. I [SURGEON] USED A BONE TAMP AND REMOVED THE CERAMIC HEAD. THE TRUNNION WAS IN GOOD CONDITION. ¿ I USED A SCREWDRIVER AND REMOVED THE ACETABULAR LINER AND COULD SEE SIGNIFICANT WEAR SUPEROLATERALLY. I USED A SCREWDRIVER AND REMOVED THE SCREWS IN THE ACETABULUM. THESE SCREWS NO LONGER HAD PURCHASE. THERE WAS OSTEOLYSIS AROUND THE SCREWS AND THEY WERE LOOSE. ¿ THE CUP WAS STABLE AND WELL FIXED." BASED ON THE EVENT DESCRIPTION, THE WEAR ON THE TIBIAL INSERT APPEARS TO BE UNEVEN. THIS COULD INDICATE INSTABILITY AND/OR RELATIVE COMPONENT MALPOSITION. ADDITIONALLY, THE POLYETHYLENE WEAR DEBRIS MAY HAVE CONTRIBUTED TO THE OSTEOLYSIS, WHICH IN TURN MAY HAVE LED TO LOSS OF BONY PURCHASE OF THE SCREWS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136696 ALTEON 6.5MM SCREW, 30MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH EXACTECH, INC. 10885862272669

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization| R