BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 22/200

    MDR report key: 10327850 · Received July 27, 2020

    Report

    Report Number
    0009613350-2020-00341
    Event Type
    Injury
    Date Received
    July 27, 2020
    Date of Event
    July 17, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ZIMMERSWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A REVITAN STEM IN 2008 AND REVISED ON (B)(6) 2020 DUE TO IMPLANT FRACTURE. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. X-RAYS: ONE PHOTOGRAPH IN JPG FORMAT OF AN AP RIGHT HIP X-RAY PHOTOGRAPHED OFF A SCREEN IN THE OR HAS BEEN RECEIVED. THE IMAGE QUALITY IS POOR DUE TO REFLECTIONS AND LOW IMAGE CONTRAST. RADIOLOGICALLY VISIBLE PIN FRACTURE OF THE DISTAL REVITAN COMPONENT. THREE CERCLAGE WIRES NOTED. THE IMAGE SHOWS POSSIBLE INSUFFICIENT BONY SUPPORT OF THE PROXIMAL REVITAN COMPONENT. FURTHER, BASED ON THE LENGTH RATIOS IT CAN BE ASSUMED THAT THE LENGTH OF THE DISTAL REVITAN COMPONENT IS 200 AND THE PROXIMAL REVITAN COMPONENT IS SIZE 55 OR 65. A DETAILED ASSESSMENT WAS NOT POSSIBLE DUE TO MISSING BASELINE FILM FOR COMPARISON. CALCULATION OF LENGTH RATIOS (PLEASE NOTE, DUE TO THE PERSPECTIVE OF THE X-RAY IMAGE THE CALCULATED LENGTHS ARE ONLY ESTIMATES): 22MM (DIAMETER ACCORDING TO DRAWING) / 1.39MM (MEASURED VALUE) = 15.83 (MULTIPLIER) 11.58MM (MEASURED LENGTH DIST. PART) 15.83 = 183MM (EXPECTED LENGTH OF DISTAL STEM IS 200) 3.078MM (MEASURED LENGTH PROX. PART) 15.83 = 48.7MM (EXPECTED LENGTH OF PROXIMAL STEM IS 55 OR 65). PATIENT DATA: MALE, BORN (B)(6) 1955, 150 KG, 195 CM, BMI: 39.5 . PRODUCT EVALUATION: NO PRODUCT WAS RETURNED DUE TO HOSPITAL POLICY; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY THE COMPLAINED PRODUCT IS KNOWN. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A REVITAN STEM IN 2008 AND REVISED ON (B)(6) 2020 DUE TO IMPLANT FRACTURE. BASED ON THE RECEIVED X-RAY A PIN FRACTURE OF THE DISTAL REVITAN COMPONENT CAN BE CONFIRMED. THE CALCULATED LENGTH RATIOS SUGGEST THAT THE PROXIMAL PART IS SIZE 55 OR 65. SUPPORTED BY THE PAPER OF HEROLD ET. AL. THE SHORT PROXIMAL PART, THE PATIENT'S INCREASED BMI AND THE INSUFFICIENT BONY SUPPORT OF THE PROXIMAL PART SUGGEST THAT THE MALE PATIENT WAS AT HIGHER RISK OF STEM FRACTURE. DUE TO SIGNIFICANT LACK OF INFORMATION A DETAILED INVESTIGATION COULD NOT BE PERFORMED, NEVERTHELESS BASED ON THE GIVEN INFORMATION THERE IS NO INDICATION OF A NON-CONFORMANCE OR COMPLAINT OUT OF BOX (COOB). IN SUMMARY, PATIENT- AND PROCEDURE-RELATED FACTORS MAY HAVE INCREASED THE RISK OF STEM FRACTURE IN THIS PATIENT, BUT DUE TO THE UNAVAILABILITY OF THE PRODUCTS AND THE LACK OF MEDICAL RECORDS, IT WAS NEITHER POSSIBLE TO CONDUCT AN IN-DEPTH INVESTIGATION NOR TO DETERMINE THE EXACT CAUSE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: REVITAN PROXIMAL STEM HIP IMPL WIN GEN; CATALOG NO#: UNKNOWN; LOT#: UNKNOWN. THERAPY DATE: (B)(6) 2020. THE MANUFACTURER DID RECEIVE X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791901 REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 22/200 REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 22/200 KWA ZIMMERSWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R