BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM 7CM DIAPHYSEAL SEGMENT

    MDR report key: 10905907 · Received November 25, 2020

    Report

    Report Number
    0001825034-2020-04217
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 2, 2020
    Report Date
    April 26, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H10. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. PHOTOGRAPHS WERE PROVIDED, WHICH SHOWED THE INTRAOPERATIVE SITE WITH THE TIBIAL BODY CONNECTED TO THE DIAPHYSEAL SEGMENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11 - CONCOMITANT DEVICES - ORTHOPEDIC SALVAGE SYSTEM MODULAR PROXIMAL TIBIAL BODY 9CM. CATALOG #: 161027 LOT #: 510700, ORTHOPEDIC SALVAGE SYSTEM 3CM DIAPHYSEAL SEGMENT. CATALOG #: 150464 LOT #: 517270. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2020-04217, 0001825034-2020-04218, AND 0001825034-2020-04387.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ORTHOPEDIC SALVAGE SYSTEM MODULAR PROXIMAL TIBIAL BODY 9CM CATALOG #: 161027 LOT #: NI, ORTHOPEDIC SALVAGE SYSTEM FEMORAL DIAPHYSEAL COUPLER 30CM CATALOG #: 150463 LOT #: NI REPORT SOURCE: (B)(6). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2020-04218.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A KNEE ARTHROPLASTY REVISION TO ADDRESS UNRELATED REASONS, THE SURGEON ATTEMPTED TO ADJUST THE TIBIAL LENGTH. HOWEVER, AFTER REMOVING THE SCREWS BETWEEN THE TIBIAL BODY AND DIAPHYSEAL SEGMENT, THE SURGEON WAS UNABLE TO DISENGAGE THE IMPLANT TAPER LOCK. THE SURGERY WAS COMPLETED WITHOUT EXTENDING THE TIBIAL LENGTH AND IT IS UNKNOWN WHETHER AN ADDITIONAL SURGERY HAS BEEN PLANNED, HOWEVER, THE SURGEON HAS REQUESTED FURTHER INSTRUCTIONS IN ORDER TO LENGTHEN THE TIBIA AT A LATER DATE. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369751 ORTHOPEDIC SALVAGE SYSTEM 7CM DIAPHYSEAL SEGMENT PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 013430

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE