BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ARTICULAR SURFACE

    MDR report key: 8106190 · Received November 27, 2018

    Report

    Report Number
    0001822565-2018-06598
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 29, 2018
    Report Date
    August 28, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K121771
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D2 - DEVICE PRODUCT CODE SHOULD BE UNKNOWN AS PRODUCT ID IS UNKNOWN. D4 - EXPIRATION DATE SHOULD BE UNKNOWN AS PRODUCT ID IS UNKNOWN. D6 - IMPLANT DATE - UNKNOWN DAY IN (B)(6) 2018. H4 - MANUFACTURING DATE SHOULD BE UNKNOWN AS PRODUCT ID IS UNKNOWN. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PATIENT'S MEDICAL RECORDS. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MEDICAL RECORDS REVIEW FROM THE INITIAL SURGERY ON (B)(6) 2017 IDENTIFIED NO COMPLICATIONS. REVIEW OF THE OFFICE VISIT NOTES FROM (B)(6) 2018 IDENTIFIED THE PATIENT WAS EXPERIENCING PAIN AND MOBILITY ISSUES. REVIEW OF THE NOTES FROM THE REVISION SURGERY ON (B)(6) 2018 IDENTIFIED THE PATIENT WAS UNABLE TO STRAIGHTEN THEIR LEG PREOP. REVIEW OF THE PROVIDED X-RAYS IDENTIFIED LIMITED EVALUATION WAS POSSIBLE GIVEN THE PATIENT POSITIONING. NO EVIDENCE OF LOOSENING OR FRACTURE WAS NOTED IN THE X-RAY REVIEW. 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

    IT WAS FURTHER REPORTED THROUGH PATIENT'S MEDICAL RECORDS THAT THE PATIENT HAD MOBILITY ISSUES AND USED A WHEEL CHAIR AS AN ASSISTIVE AID. FURTHER, THE PATIENT ALLEGED SEVERE PAIN, LOCKING, SWELLING, AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR) CATALOG # 42502606402, LOT # 63863873; PERSONA STEMMED TIBIA CATALOG # 42532007502, LOT # 63744235. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 3007963827-2018-00209. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY, SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO STIFFNESS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945749 UNKNOWN ARTICULAR SURFACE PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 62360943

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R