BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20 SILICONE PIP IMPLANT (STERILE PACKED)

    MDR report key: 17726685 · Received September 11, 2023

    Report

    Report Number
    1644408-2023-01233
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    August 14, 2023
    Report Date
    November 28, 2023
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    KYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY, THE AGENT REPORTED "(IMPLANT REMOVAL DUE TO BREAKAGE AND LOCALISED RESPONSE. IMPLANTED BY MR. REP PRESENT DURING IMPLANTATION. NO ISSUES IMPLANTING IMPLANT. GOOD POST-OP RESULT. PATIENT RE-PRESENTED WITH REDNESS AND PAIN. SAMPLES SUGGEST NO PRESENCE OF INFECTION. IMPLANT REMOVED DUE TO CONTINUED PAIN LAST WEEK, SIGNS OF BONE EROSION, 2-STAGE-REVISION. NO OTHER IMPLANT REPLACED SO FAR. SILICONE BRIDGE REPORTED AS SEPARATED. SAMPLES TAKEN. NO GROWTH AS YET FOR INFECTION. PER REQUIRED ON IMPLANT. IMPLANT AVAILABLE FROM (NON-DECONTAMINATED AT PRESENT). HOSPITAL WAS REQUESTED TO DECONTAMINATE IMPLANT AND RETURN TO OSTEOTEC FOR QUARANTINE)." THE ACTUAL LENGTH OF IN-VIVO FOR THE ITEM(S) LISTED IS UNKNOWN AS THE ORIGINAL SURGERY DATE OR DTICKETS WERE NOT PROVIDED TO DETERMINE IT. THIS EVALUATION IS LIMITED IN SCOPE AS THE ITEM(S) ASSOCIATED WITH THIS INVESTIGATION WAS NOT RETURNED TO DJO SURGICAL - AUSTIN FOR EXAMINATION. THE SURGERY WAS COMPLETED AS INTENDED AND WITHOUT INCIDENT. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THAT THE REPORTED DEVICE(S) WAS DEFECTIVE. THE SURGEON PERFORMED THIS PROCEDURE TO REMEDY THE PATIENT'S CONDITION. NO FURTHER ACTION IS DEEMED NECESSARY. A REVIEW OF THE DEVICE HISTORY RECORD(S) SHOW THAT THE REPORTED COMPONENT(S) USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NONCONFORMING MATERIAL REPORTS ASSOCIATED WITH THE PRODUCT(S) THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE(S) WAS VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE(S) SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY IMPLANT REMOVAL DUE TO BREAKAGE AND LOCALISED RESPONSE. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104904 20 SILICONE PIP IMPLANT (STERILE PACKED) PROSTHESIS, FINGER, CONSTRAINED, POLYMER KYJ ENCORE MEDICAL L.P 13560D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention