BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNPLUG CEMENT RESTRICTOR

    MDR report key: 16545792 · Received March 15, 2023

    Report

    Report Number
    3001503333-2023-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 15, 2023
    Report Date
    March 14, 2023
    Manufacturer
    ISOTIS ORTHOBIOLOGICS INC.
    Product Code
    LZN
    PMA / PMN Number
    K010840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RADIOGRAPHS PROVIDED INDICATE THE BIODEGRADABLE CEMENT RESTRICTOR HAS DEGRADED; LITERATURE SUGGESTS FURTHER DETERIORATION OF THE HIP PROSTHESIS MAY OCCUR, PLACING THE JOINT AT RISK OF FRACTURE. ALTHOUGH IT IS ASSOCIATED WITH OSTEOLYSIS, IT IS NOT CLEAR IF THE PHENOMENON IS CAUSED BY THE DEVICE OR IF OTHER PHYSIOLOGIC PROCESSES/INTERACTIONS ARE CONTRIBUTORY. FIELD SAFETY CORRECTIVE ACTION (FSCA-O-HHE-701) WAS UNDERTAKEN TO PROVIDE SAFETY ALERT TO PHYSICIANS REGARDING THE POSSIBLE RISK. AT OR AROUND THAT TIME (2014), MARKET WITHDRAWAL AND DESTRUCTION OF UNUSED PRODUCT OCCURRED. THE PROSTHESIS REMAINS IMPLANTED; NO REVISION HAS OCCURRED. THIS IS CONSISTENT WITH THE MAJORITY OF SIMILAR REPORTS.

    Description of Event or Problem · 0

    OSTEOLYSIS IN THE AREA OF THE SYNPLUG WAS OBSERVED VIA RADIOGRAPHY DURING A FOLLOW-UP VISIT 12 YEARS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768699 SYNPLUG CEMENT RESTRICTOR CEMENT OBTURATOR LZN ISOTIS ORTHOBIOLOGICS INC. 804022 200378B

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown