BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    MDR report key: 17599790 · Received August 22, 2023

    Report

    Report Number
    0009613350-2023-00469
    Event Type
    Injury
    Date Received
    August 22, 2023
    Report Date
    October 9, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KTT
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. G4: THIS PRODUCT IS NOT CLEARED IN THE US, HOWEVER IS CONSIDERED EQUIVALENT TO 510K K000734. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF MANUFACTURING RECORDS CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. THE DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. IT IS EXPECTED THAT A WOUND HEALS IN STAGES AND SHOULD BE OF NORMAL APPEARANCE RELATED TO THE TIMEFRAME SINCE THE INCISION WAS MADE. A SURGICAL WOUND SHOULD BE WELL APPROXIMATED WITHOUT REDNESS, WARMTH, SWELLING AND/OR PURULENT DRAINAGE FOR THE DURATION OF ITS HEALING. THE EXPRESSION ¿WOUND CONCERNS¿ OR "NON-HEALING WOUND¿ WOULD IMPLY THAT THE APPEARANCE OF THE WOUND DEVIATES FROM WHAT A SURGICAL WOUND SHOULD APPEAR. IT MAY BE RED, HAVE DRAINAGE, ADDITIONAL PAIN, WARMTH AND SWELLING AS WELL AS HEALING TIME MAY BE DELAYED. THIS DEVIATION SIGNIFIES AN ALTERATION IN THE WOUND HEALING PROCESS WHICH CAN BE COMPLICATED BY PATIENT COMORBIDITIES SUCH AS DIABETES, OBESITY, SMOKING, AND OTHER CONDITIONS THAT ARE KNOWN TO SLOW A PERSON¿S ABILITY TO HEAL. WOUND COMPLICATIONS CAN BE TREATED CONSERVATIVELY OR MORE INVASIVELY WITH IRRIGATION AND DEBRIDEMENT (I&D) OR RESUTURING OF A DEHISCENCE WHICH PROMOTES HEALING AT THE SITE AND PREVENTS FURTHER COMPLICATIONS. ANTIBIOTIC OINTMENT OR PADS ARE ROUTINELY APPLIED TO PREVENT INFECTION. SUPERFICIAL INFECTIONS ARE CONSIDERED A PROCEDURE-RELATED COMPLICATION AS NO DEVICE HAS BEEN REPORTED AS REVISED. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER-RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. DURING THE INVESTIGATION PROCESS, A REVIEW OF THE STERILE CERTIFICATIONS WAS NOT REVIEWED, AS NO PRODUCT PART/LOT INFORMATION WAS PROVIDED. ALL DEVICES MANUFACTURED FOLLOW ACCEPTABLE STERILIZATION PROCESSES ACCORDING TO PUBLISHED ISO/AAMI/ASTM & EU GUIDELINES. A SUPERFICIAL INFECTION WAS REPORTED AND NO PRODUCT INFORMATION WAS PROVIDED; THEREFORE, VALIDATION OF STERILE CERTIFICATIONS CANNOT BE PERFORMED. HOWEVER, THE REPORTED EVENT IS CONSIDERED PROCEDURE-RELATED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : ITEM NUMBER AND LOT NUMBER UNKNOWN.

    Additional Manufacturer Narrative · 0

    (B)(4). G2 ¿ FOREIGN ¿ GERMANY. H3 ¿ OTHER: DEVICE EVALUATION COULD NOT BE PERFORMED AS PART# AND LOT# ARE UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ADDITIONAL MEDICAL INTERVENTION AND CLOSURE OF WOUND WITH ANTIBIOTIC PADS DUE TO SLOW WOUND HEALING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246957 UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE INTERNAL ORTHOPEDIC FIXATION SYSTEM, PLATE/SCREW KTT ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN
    45172 UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE INTERNAL ORTHOPEDIC FIXATION SYSTEM, PLATE/SCREW KTT ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H