BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNPLUG - UNKNOWN SIZE

    MDR report key: 4972552 · Received August 3, 2015

    Report

    Report Number
    2090010-2015-00032
    Event Type
    Injury
    Date Received
    August 3, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ISOTIS ORTHOBIOLOGICS, INC
    Product Code
    LZN
    PMA / PMN Number
    K010840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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 AND OPTIPLUG BIODEGRADEABLE 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 FINDINGS 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 07/08/2015 INDICATED ADVERSE EVENTS FOR 3 PATIENTS HAD BEEN REPORTED TO THE AUTHORITY. AT THIS TIME, IT IS UNCLEAR IF THE INFORMATION PROVIDED TO INTEGRA BY THE AUTHORITY REGARDS PATIENTS/ADVERSE EVENTS INTEGRA HAS ALREADY PROVIDED MDR'S FOR OR IF THEY RELATE TO NEW PATIENTS/ADVERSE EVENTS. INTEGRA HAS CONTACTED THE SWISS HOSPITAL DIRECTLY TO ASCERTAIN THIS AS WELL AS ADDITIONAL INFORMATION AND IN THE INTERIM IS SUBMITTING 3 MDR'S FOR THESE REPORTS. SHOULD THE ADDITIONAL INFORMATION INDICATE ANY OF THE 3 ADVERSE EVENTS RELATE TO PATIENT/ADVERSE EVENTS INTEGRA HAS ALREADY PROVIDED MDR'S FOR, IT WILL BE NOTED IN A FOLLOW-UP MDR. THIS REPORT IS FOR PATIENT 3 OF THE 3 PATIENTS. THE NARRATIVE AND DETAILS OF THIS EVENT HAVE BEEN TRANSLATED FROM (B)(6) AS FOLLOWS: DIAGNOSES: STATUS POST TOTAL HIP PROSTHESIS IMPLANT ON THE LEFT SIDE OF (B)(6) 2010 AND TOTAL HIP PROSTHESIS IMPLANT ON THE RIGHT SIDE OF (B)(6) 2010. DISCRETE OSTEOLYSES WITH SYNPLUG CEMENT BLOCKS PROGRESSION. THE PLANNED 5-YEAR PROGRESS CHECK-UP TAKES PLACE AFTER IMPLANTATION. THE PATIENT IS VERY SATISFIED WITH THE TWO PROSTHESES, AND IS PARTICULARLY FREE OF PAIN. SHE IS MOBILE WITH A CANE FOR SAFETY WHEN SHE IS OUT OF THE HOUSE. SHE DOES NOT USE A CANE FOR SHORTER DISTANCES AND AT HOME. FINDINGS: FLUID GAIT, EVENT WITHOUT A CANE. KNOWN OBESITY. UNIRRITATED WOUND CONDITIONS BILATERALLY. PAINLESS MOBILITY IN BOTH HIP JOINTS WITH EXTENSION/FLEXION BILATERALLY 0/0/110, OUTER ROTATION/INNER ROTATION 30/0/25. NO PAIN WHEN SHAKEN AND NO AXIAL SHOCK PAIN. X-RAY: PELVIC OVERVIEW AND HIP JOINTS BILATERALLY, AXIALLY: NORMAL POSITION OF THE PROSTHESES ON BOTH SIDES WITHOUT SIGNS OF LOOSENING. COMPARED TO THE PREVIOUS EXAMINATION OF (B)(6) 2011, PROGREDIENT DISCRETE LYSIS SIGNS DISTALLY FROM THE DISTAL PROSTHESIS SHAFT ON BOTH SIDES, RIGHT GREATER THAN LEFT. FURTHER PROCEDURE: NO INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503184 SYNPLUG - UNKNOWN SIZE SYNPLUG LZN ISOTIS ORTHOBIOLOGICS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention