BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN®, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140

    MDR report key: 19818569 · Received July 24, 2024

    Report

    Report Number
    0009613350-2024-00304
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    July 1, 2024
    Report Date
    December 12, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWC
    UDI-DI
    00889024593015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # 0100401075, REVITAN®, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14, LOT # 2803000. ITEM # 00877503604, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14, LOT # 2791392. G2: REPORT SOURCE SWITZERLAND. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, D9, E1, G3, G6, H2, H3, H6, H11 THE REPORTED PRODUCT AS WELL AS THE PROXIMAL COMPONENT AND THE FEMORAL HEAD WERE RETURNED TO THE POST MARKET SURVEILLANCE TEAM FOR EXAMINATION. THE PROXIMAL COMPONENT WAS RETURNED STILL ASSEMBLED WITH THE FEMORAL HEAD. THE REPORTED EVENT OF FRACTURE AT THE PIN CONNECTION OF THE DISTAL COMPONENT CAN BE CONFIRMED. THERE ARE SEVERAL SCRATCHES OF VARYING DEPTHS TO BE SEEN ON THE PROXIMAL COMPONENT, DISTAL COMPONENT AND ON THE FEMORAL HEAD, LIKELY STEMMING FROM THE REVISION SURGERY. SOME BONE RESIDUE IS PRESENT ALONG THE DISTAL COMPONENT. THE FRACTURE SURFACE OF BOTH THE DISTAL AND PROXIMAL COMPONENT WERE FURTHER EXAMINED. BEACH LINES CAN BE OBSERVED ON BOTH COMPONENTS, ORIGINATING FROM THE LATERAL SIDE TO THE MEDIAL SIDE OF THE COMPONENTS. THESE BEACH LINES ARE INDICATIVE OF A FATIGUE FRACTURE. THERE ARE ALSO SEVERAL POLISHED SURFACES AND DAMAGES TO BE SEEN ON THE FRACTURE SURFACE, LIKELY DUE TO CONTACT OF THE COMPONENTS AFTER THE FRACTURE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. AN IMAGE SHOWING THE FIRST PAGE OF THE SURGICAL REPORT FOR THE IMPLANTATION WAS PROVIDED AND REVIEWED. THE PATIENT PREVIOUSLY HAD A THA 15 YEARS AGO (METASUL PAIRING, CEMENTLESS FITMORE SHELL, CEMENTED VIRTEC SHAFT) AND UNDERWENT REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE SHAFT. THE SHELL WAS LEFT IN-SITU AND THE INSERT AND STEM WERE REVISED. A DURASUL INSERT 36MM, REVITAN STEM AND BIOLOX FEMORAL HEAD WERE IMPLANTED. BASED ON THE INVESTIGATION, A FRACTURE OF THE CONNECTION PIN OF THE REVITAN STEM CAN BE CONFIRMED. THE CHARACTERISTICS OF THE FRACTURE SURFACES POINT TO A FATIGUE FRACTURE. THE CAUSE MAY BE MULTIFACTORIAL, CONSISTING OF PATIENT- AND PROCEDURE-RELATED FACTORS. NEVERTHELESS, WITH THE INFORMATION PROVIDED, WE ARE UNABLE TO PROVIDE FURTHER ANALYSIS OF THE COMPLAINT REPORTED OR DRAW ANY DEFINITIVE CONCLUSIONS AS TO THE ROOT CAUSE OF THE REPORTED ISSUE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO PAIN. UPON SURGERY IT WAS FOUND THAT THE REVITAN STEM WAS BROKEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2408577 REVITAN®, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140 PROSTHESIS, HIP HWC ZIMMER GMBH N/A 2793538 00889024593015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R