BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN TIBIA TRAY COMPONENT

    MDR report key: 10185878 · Received June 23, 2020

    Report

    Report Number
    0001822565-2020-02212
    Event Type
    Death
    Date Received
    June 23, 2020
    Report Date
    July 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AS. IT MAY BE RED, HAVE DRAINAGE, ADDITIONAL PAIN, WARMTH AND SWELLING AS WELL AS HEALING TIME MAY BE DELAYED. ANY INVASIVE SURGICAL PROCEDURE, INCREASES THE RISK FOR DEVELOPMENT OF A POSTOPERATIVE INFECTION. THE PROCEDURE BREAKS THE SKINS NATURAL PROTECTIVE LAYER ALLOWING ENTRY POINTS FOR BACTERIA TO BE INTRODUCED INTO THE BODY. PROPHYLACTIC USE OF ANTIBIOTICS PRIOR TO INITIAL INCISION IN TOTAL JOINT ARTHROPLASTY IS CONSIDERED AN APPROPRIATE USE OF ANTIBIOTICS TO PREVENT INFECTION ALONG WITH POSTOPERATIVE TREATMENT FOR 24 TO 48HRS. THE PROPHYLACTIC TREATMENT DOES NOT SIGNIFY TREATMENT OF INFECTION, BUT CURRENT STANDARD OF CARE AND NOT AN ABNORMAL FINDING. ACCORDING TO THE CENTER FOR DISEASE CONTROL. IN CLEAN OR CLEAN-CONTAMINATED PROSTHETIC JOINT ARTHROPLASTIES, DO NOT ADMINISTER ADDITIONAL ANTIMICROBIAL PROPHYLAXIS DOSES AFTER THE SURGICAL INCISION IS CLOSED IN THE OR, EVEN IN THE PRESENCE OF A DRAIN STRONG RECOMMENDATION; HIGH-QUALITY EVIDENCE. ADDITIONALLY, THE CDC STATES ANTIBIOTICS ARE ONLY NEEDED FOR TREATING CERTAIN INFECTIONS CAUSED BY BACTERIA. THEREFORE, IF AN ANTIBIOTIC HAS BEEN ADMINISTERED BEYOND THE NORMAL INTRAOPERATIVE AND POSTOPERATIVE STANDARD OF CARE TREATMENT TIME FRAME, IT CAN BE IMPLIED IT WAS UTILIZED TO TREAT A SUSPECTED BACTERIAL INFECTION. AS DOCUMENTATION OF ORAL ANTIBIOTIC WITH NO FURTHER TREATMENT FOR WOUND CONCERNS OR DEEP INFECTION IT CAN BE CONCLUDED THE TREATMENT WAS USED TO TREAT A SUPERFICIAL INFECTION. THIS DEVIATION SIGNIFIES AN ALTERATION IN THE WOUND HEALING PROCESS AND OUR COMPLAINT CATEGORY, MEDICAL INFECTION SUPERFICIAL AND MEDICAL SURGICAL SITE WOUND COMPLICATION WOULD APPLY. 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FEMORAL COMPONENT, ITEM UNKNOWN, LOT UNKNOWN. BEARING COMPONENT, ITEM UNKNOWN, LOT UNKNOWN. REPORT SOURCE: PETRILLO, S., MARULLO, M., CORBELLA, M., PERAZZO, P., & ROMAGNOLI, S. (2019). ONE-STAGED COMBINED HIP AND KNEE ARTHROPLASTY: RETROSPECTIVE COMPARATIVE STUDY AT MID-TERM FOLLOW-UP. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH, 14(1). HTTPS://DOI.ORG/10.1186/S13018-019-1337-0. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-02211, 0001822565-2020-02213. (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STUDY REPORTED ONE PATIENT IN GROUP A EXPERIENCED A SURGICAL WOUND INFECTION WITHIN 1 MONTH OF SURGERY AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650982 UNKNOWN TIBIA TRAY COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other