BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCIA T PLASMAPORE 12/14 SIZE 15MM

    MDR report key: 6094458 · Received November 10, 2016

    Report

    Report Number
    3005673311-2016-00190
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    June 23, 2016
    Report Date
    June 28, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    LZO
    PMA / PMN Number
    K140915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DUE TO THE CIRCUMSTANCES THAT THE DEVICES ARE NOT AVAILABLE AN INVESTIGATION AT THE IMPLANTS IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. CONCLUSION AND ROOT CAUSE: DUE TO FURTHER EXPERIENCES THE MENTIONED FAILURE IS MOST PROBABLY PATIENT, RESPECTIVE USER RELATED. RATIONAL: A ROOT CAUSE FOR THIS FAILURE COULD BE A BAD BONE CONDITION OF THE PATIENT. IN THE IFU IS CLEARLY MENTIONED: DO NOT USE IN THE PRESENCE OF: ACUTE OSTEOPOROSES OR OSTEOMALACIA. ANOTHER ROOT CAUSE COULD BE A WRONG PREPARATION OF THE BONE BED BY THE SURGEON. CORRECTIVE ACTION: ACCORDING TO SOP (B)(4) A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). IT IS REPORTED THAT PATIENT WAS SUFFERING PAIN IN REHAB CLINIC REVISION DUE TO PERIPROSTHETIC FRACTURE. ORIGINAL SURGERY DATE REPORTED AS (B)(6) 2016. REVISION SURGERY DATE REPORTED AS (B)(6) 2016. COMPONENTS IN USE CONCOMITANT DEVICES ARE: NU215T - EXCIA T PLASMAPORE 12/14 SIZE 15MM. NV054T - PLASMAFIT POLY SIZE 52MM I. NK561D - BIOLOX DELTA PROSTH. HEAD 12/14 32MM M. NV205E - VITELENE INSERT I 32MM SYM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743156 EXCIA T PLASMAPORE 12/14 SIZE 15MM HIP ENDOPROSTHETICS LZO AESCULAP IMPLANT SYSTEMS NU215T 52216874

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other| R NK561D / BIOLOX DELTA PROSTH.HEAD 12/14 32MM M| NV205E / VITELENE INSERT I 32MM SYM.| NVO54T / PLASMAFIT POLY CUP SIZE 52MM I