BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 20/140

    MDR report key: 15193485 · Received August 9, 2022

    Report

    Report Number
    0009613350-2022-00413
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    June 29, 2022
    Report Date
    November 24, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    UDI-DI
    00889024592933
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE - FOREIGN-GERMANY. CONCOMITANT MEDICAL PRODUCTS: REVITAN PROXIMAL STEM, ITEM NUMBER AND LOT NUMBER UNKNOWN. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT NUMBERS HAVE BEEN PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10 SULOX, HEAD, M, 32/0, TAPER 12/14; ITEM: 173206, LOT: 279884. REVITAN®, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14; ITEM: 0100402055, LOT: 2777752. VISUAL EXAMINATION OF THE RETURNED PRODUCT SHOWED THAT THE SULOX HEAD LOOKS INCONSPICUOUS WITH SOME SLIGHT METALLIC SMEARING DERIVING MOST LIKELY FROM THE REMOVAL. THE DISTAL AND PROXIMAL COMPONENTS OF THE REVITAN STEM SHOW DAMAGES FROM THE REVISION SURGERY IN THE FORM OF SCRATCHES AND NICKS. NO BONE ON GROWTH CAN BE SEEN ON THE ANCHORING SURFACE OF THE PROXIMAL COMPONENT. ON THE MEDIAL SIDE, THE PROXIMAL COMPONENT HAS A FINE POLISH, WHICH POSSIBLY DERIVED FROM MICROMOTIONS AGAINST BONE. ONLY LITTLE BONE ATTACHMENTS CAN BE FOUND ON THE ANCHORING SURFACE OF THE DISTAL COMPONENT. THE CONNECTION PIN OF THE DISTAL COMPONENT IS FRACTURED IN THE NOT BLASTED AREA. THE FRACTURE SURFACES POINT TO A FATIGUE FRACTURE WITH THE ORIGIN LOCATED ON THE LATERAL SIDE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A REVISION DUE TO AN IMPLANT FRACTURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE, NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

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

    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
    287784 REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 20/140 HIP PROTHESIS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2786473 00889024592933

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE.| SEE H10 NARRATIVE.