BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR CMPL HA HO COL SIZE 4

    MDR report key: 10683758 · Received October 15, 2020

    Report

    Report Number
    0001822565-2020-03549
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 15, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K182048
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 30103203-G7 VIT E NEUTRAL LNR 32MM C-64669012, 010000661-G7 PPS LTD ACET SHELL 48C-6721216, 00877503201-BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14-3013059, MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 -2020 - 03547. 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. IT IS NOTED AN I&D (INCISION & DEBRIDEMENT) WAS PERFORMED ON THE SUPERFICIAL NON-HEALING WOUND. AN I&D PROCEDURE CAN BE USED TO PROMOTE THE HEALING PROCESS, AND THIS IS A COMMON PROCEDURE USED TO TREAT A NON-HEALING INCISION SITE. THE REPORTED EVENT OF SUPERFICIAL INFECTION <30 DAYS OCCURRED POST IMPLANTATION. SUPERFICIAL INFECTIONS OCCURRING <30 DAYS FROM IMPLANTATION 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 WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS, FURTHER ELIMINATING THE IMPLANTED DEVICES AS A POTENTIAL SOURCE FOR THE REPORTED INFECTION. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. AS DEVICE HAS NOT BEEN INDICATED AS REVISED AND THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT REQUIRED A WOUND DEBRIDEMENT DUE TO A SUPERFICIAL INFECTION APPROXIMATELY 1-MONTH POST IMPLANTATION. NO PRODUCT WAS EXCHANGED. PATIENT REPORTED SATISFACTION AND NO OTHER COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150589 AVENIR CMPL HA HO COL SIZE 4 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 3012866

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R