BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNPLUG - UNKNOWN SIZE

    MDR report key: 5082232 · Received September 16, 2015

    Report

    Report Number
    2090010-2015-00037
    Event Type
    Injury
    Date Received
    September 16, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 18, 2015
    Manufacturer
    ISOTIS ORTHOBIOLOGICS, INC
    Product Code
    LZN
    PMA / PMN Number
    K010840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THERE ARE NO CONCLUSIVE FINDINGS FROM THIS OR SIMILAR COMPLAINT INVESTIGATIONS, OR FROM TECHNICAL OR CLINICAL INFORMATION IN THE LITERATURE THAT PROVES OR DISPROVES A CAUSAL RELATIONSHIP BETWEEN SYNPLUG® & OPTIPLUG® BIODEGRADABLE CEMENT RESTRICTORS OR THE MATERIALS THEY ARE MANUFACTURED WITH, AND PERIPROSTHETIC OSTEOLYSIS (OR FRACTURES AS A RESULT). THERE ARE ALSO NO DATA OR FINDINGS THAT WOULD SUGGEST THAT ONLY SOME SUBSET OF ALL THE PRODUCTS MANUFACTURED MIGHT BE AFFECTED. THE FINDING OF OSTEOLYSIS SURROUNDING THE DISTAL CEMENT RESTRICTOR IS UNEXPECTED, AND UNDESIRABLE; HOWEVER, PERIPROSTHETIC OSTEOLYSIS IN TOTAL HIP ARTHROPLASTY IS A WELL-KNOWN PROBLEM THAT IS TYPICALLY A MULTIFACTORIAL PROCESS AND MAY BE IDENTIFIED THROUGH ROUTINE RADIOGRAPHIC FOLLOW-UP.

    Description of Event or Problem · 1

    INTEGRA RECEIVED AN INQUIRY FROM THE (B)(4) REGARDING REPORTS THEY HAD RECEIVED FROM A (B)(6) HOSPITAL REGARDING OSTEOLYSIS. THE INQUIRY RECEIVED ON 18AUG2015 INDICATED FOLLOW UP FOR AN ADVERSE EVENT HAD BEEN REPORTED TO THE AUTHORITY. AT THIS TIME, IT IS UNCLEAR IF THE INFORMATION PROVIDED TO INTEGRA BY THE AUTHORITY REGARDS A PATIENT / ADVERSE EVENT INTEGRA HAS ALREADY PROVIDED AN MDR'S FOR OR IF THIS RELATES TO A NEW PATIENT / ADVERSE EVENT. INTEGRA HAS CONTACTED THE (B)(6) HOSPITAL DIRECTLY TO ASCERTAIN THIS AS WELL AS ADDITIONAL INFORMATION AND IN THE INTERIM IS SUBMITTING THIS MDR. SHOULD THE ADDITIONAL INFORMATION INDICATE THE ADVERSE EVENT RELATES TO PATIENTS / ADVERSE EVENTS INTEGRA HAS ALREADY PROVIDED MDR'S FOR, IT WILL BE NOTED IN A FOLLOW-UP MDR. THE NARRATIVE AND DETAILS OF THIS EVENT HAVE BEEN TRANSLATED FROM GERMAN AS FOLLOWS: WE HEREWITH REPORT TO YOU ABOUT THE OUTPATIENT EXAMINATION (FOLLOW-UP) OF THE AFOREMENTIONED PATIENT OF (B)(6) 2015. DIAGNOSIS STATUS AFTER TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2010 PROGRESSION PLANNED POSTOPERATIVE CLINICAL AND RADIOLOGICAL FOLLOW-UPS AFTER 5 YEARS. THE PATIENT IS FEELING GOOD. NO PAINS. THE PATIENT STILL SUFFERS FROM OCCASIONAL VERTIGO AND WE ARE CLARIFYING THIS WITH THE GENERAL PRACTITIONER. FINDINGS SMOOTH GAIT WITHOUT ANTALGIC GAIT. RIGHT HIP WITH SKIN AND SOFT TISSUE CONDITIONS FREE OF ANY IRRITATIONS AS WELL AS WELL HEALED SCAR OF THE MINIMALLY INVASIVE SURGICAL PROCEDURE. RANGE OF MOTION FLEXION/EXTENSION 120/0/0 DEGREES INTERNAL-/EXTERNAL ROTATION 20/0/40஠PERIPHERAL OMS INTACT. REST OF THE FEMUR DOES NOT SHOW PAIN ON PALPATION. X-RAY PELVIC VIEW AND AXIAL RIGHT POSITION OF THE HIP SHOW NORMAL POSITION OF THE IMPLANT WITHOUT ANY SECONDARY SIGNS OF LOOSENING. SLIGHTLY PROGRESSIVE LYSIS ZONE IN THE AREA OF THE FORMER CEMENT BLOCK. FURTHER PROCEDURE EXCELLENT POSTOPERATIVE RESULT AFTER 5 YEARS. ANOTHER FOLLOW-UP 10 YEARS AFTER SURGERY BIRTH DATE OF THE PATIENT: 1920.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613740 SYNPLUG - UNKNOWN SIZE SYNPLUG LZN ISOTIS ORTHOBIOLOGICS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Disability