BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TIBIAL COMPONENT PRECOAT SIZE 4

    MDR report key: 8077206 · Received November 16, 2018

    Report

    Report Number
    0001822565-2018-06485
    Event Type
    Injury
    Date Received
    November 16, 2018
    Report Date
    August 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: ITEM # 00576401551, LOT # 61346445; ITEM # 00597206532, LOT # 61321757; ITEM # 00596203212, LOT # 61394548. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT. INTRAOPERATIVE BLOOD LOSS WAS DOCUMENTED BUT NO OTHER COMPLICATIONS WITH THE IMPLANTS WERE NOTED. REVIEW OF THE LETTER PROVIDED BY THE PATIENT IDENTIFIED THE PATIENT WAS EXPERIENCING AN ALLERGIC REACTION POST-OPERATIVELY AND WAS RESEARCHING METAL ALLERGY. PER THE NEXGEN CR-FLEX AND LPS-FLEX GENDER SOLUTIONS PACKAGE INSERT (87-6203-762-01, REV. B), METAL SENSITIVITY IS A KNOWN POTENTIAL ADVERSE EFFECT OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PATELLA ITEM # UNKNOWN LOT # UNKNOWN, UNKNOWN FEMORAL ITEM # UNKNOWN LOT # UNKNOWN. 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: 0001822565-2018-06484, 0001822565-2018-06486. 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 PATIENT UNDERWENT KNEE ARTHROPLASTY AND SUBSEQUENTLY EXPERIENCING A RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918840 NEXGEN TIBIAL COMPONENT PRECOAT SIZE 4 JWH JWH ZIMMER BIOMET, INC. N/A 61383373

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10 NARRATIVE| SEE H10 NARRATIVE