BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PAT-SPEC CR FMRL 70 LT

    MDR report key: 9777512 · Received March 2, 2020

    Report

    Report Number
    0001825034-2020-00969
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    November 21, 2019
    Report Date
    December 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304555617
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. NO MEDICAL RECORDS WERE PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT STARTED WOUND VAC. APPROXIMATELY 7 MONTHS LATER, THE PATIENT HAD 95% WOUND CLOSURE. 3 MONTHS LATER, THE PATIENT WAS UNABLE TO INCREASE ROM DUE TO POSSIBLE SCAR TISSUE AND NOTES SWELLING. APPROXIMATELY A MONTH LATER, THE ULTRASOUND FOUND SUBCUTANEOUS FLUID COLLECTION W/SINUS TRACT TO SKIN SURFACE, SUGGESTS ABSCESS, POSSIBLY FROM CHRONIC OSTEOMYELITIS OF DISTAL FEMUR. X-RAY, INDICATIONS FOR REVIEW, MEDIAL KNEE PAIN, SWELLING, BRUISING, OPEN WOUND IN MEDIAL ASPECT; NO LOOSENING, DIFFUSE SOFT TISSUE SWELLING, JOINT EFFUSION. A 3 PHASE BONE SCAN-EXTENSIVE HO FROM HEALING PREVIOUS FRACTURE OF TIBIA. THE PATIENT PRESENTED LEFT KNEE PAIN AND REVIEW OF X-RAYS SUGGEST FEMORAL LOOSENING DUE TO INFECTION. NO MEDICAL RECORDS WERE PROVIDED TO CONFIRM AMPUTATION. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT OF DEEP INFECTION <90 DAYS OCCURRED POST IMPLANTATION. ZIMMER BIOMET CONSIDERS THIS EVENT NOT REPORTABLE DUE TO THE FOLLOWING RATIONALE. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. 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, THEREFORE 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: THERAPY DATE: UNKNOWN EP-189101 - E1 VNGD AS TIB BRG - 834110, 141215 - BIOMET ILOK PRI TIB TRAY - 252660, 141318 - BIOMET FINNED PRI STM - 815100, 184788 - SERIES A PAT THIN - 570600. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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: 0001825034-2020-00970, 0001825034-2020-00971, 0001825034-2020-00972, 0001825034-2020-00973.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT IMMEDIATELY DEVELOPED A SEVERE INFECTION AT THE SURGICAL SITE THAT RESULTED IN AMPUTATION OF THE LEG. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239607 VNGD PAT-SPEC CR FMRL 70 LT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 632810 00880304555617

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S