BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 FINNED 4 HOLE SHELL 54F

    MDR report key: 18290340 · Received December 8, 2023

    Report

    Report Number
    0001825034-2023-02914
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    July 5, 2017
    Report Date
    December 15, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K142746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 AN IRRIGATION AND DEBRIDEMENT (I&D) WHICH PROMOTES HEALING AT THE SITE AND PREVENTS FURTHER COMPLICATIONS. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. 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. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4), D10: 51-100150 ITEM NAME TPRLC 133 FP TYPE1 PPS SO 15.0 LOT# 2299334. 010000858 ITEM NAME G7 NEUTRAL E1 LINER 36MM F LOT # 6033052. 650-1057 ITEM NAME CER BIOLOXD OPTION HD 36MM LOT # 2897727. 650-1064 ITEM NAME CER OPTION TYPE 1 TPR SLEVE - 6 LOT # 2897761. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034 - 2023 - 02908, 0001825034 - 2023 - 02915. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE WEEKS POST IMPLANTATION, THE REHAB FACILITY REPORTED THAT THE INCISION AREAS WERE NOT CLOSING PROPERLY. THE PATIENT UNDERWENT WEEKLY WOUND DEBRIDEMENT'S TO ASSIST WITH CLOSURE AND A BACTERIAL INFECTION WAS CONFIRMED. THE COMPLICATION RESOLVED 4 MONTHS POSTOP. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200259 G7 FINNED 4 HOLE SHELL 54F PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 6038566

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R