BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT COMPONENT SIZE 5 GREEN PLUS (+) 0 MM THICKNESS

    MDR report key: 13451200 · Received February 4, 2022

    Report

    Report Number
    0001822565-2022-00289
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    April 1, 2021
    Report Date
    April 18, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    NTG
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00287, 0001822565-2022-00288, 0001822565-2022-00290. CONCOMITANT MEDICAL PRODUCTS: ITEM#: 00830004500, TIBIAL BASE COMPONENT SIZE 5 GREEN FOR USE WITH SIZE 5 TALAR COMPONENTS ONLY; LOT#: 63086310. ITEM#: 00830002500, TALAR COMPONENT SIZE 5 RIGHT GREEN FOR USE WITH SIZE 5 TIBIAL COMPONENTS ONLY; LOT#: 63364413. ITEM#: 00235701806, DISTAL LATERAL FIBULAR PLATE LEFT 6 HOLES 106 MM LENGTH; LOT#: 63276652. REPORT SOURCE: FOREIGN: EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. BASED ON THE INFORMATION WE HAVE RECEIVED IT WAS DETERMINED THAT THE EVENT WAS NOT RELATED TO THE IMPLANT AND IS NO LONGER CONSIDERED A REPORTABLE EVENT FOR THE THIS DEVICE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00287-1, 0001822565-2022-00288-1, 0001822565-2022-00290-1. A PATIENT UNDERWENT INITIAL RIGHT ANKLE FUSION DUE TO PROGRESSIVE CHANGES FROM RHEUMATOID ARTHRITIS, STIFFNESS, AND PREVIOUS HARDWARE THAT WAS NO LONGER PROVIDING SUFFICIENT SUPPORT TO THE JOINT. THE PATIENT INITIALLY DID WELL AFTER THE ANKLE ARTHROPLASTY BUT SHOWED SLIGHT INCREASE IN PAIN, STIFFNESS, AND SWELLING POSTOPERATIVELY WHICH CAN BE ATTRIBUTED TO THE PATIENT'S PRE-EXISTING COMORBID CONDITIONS OF RHEUMATOID ARTHRITIS AND HETEROTOPIC OSSIFICATION. THE OSSIFICATION AND RHEUMATIC CHANGES IN THE JOINT LED TO MEDIAL GUTTER IMPINGEMENT CAUSING MILD OCCASIONAL PAIN AND TENDERNESS. HETEROTOPIC OSSIFICATION IS THE ABNORMAL AND RAPID GROWTH OF BONE THAT FORMS WITHIN SOFT TISSUE AS THE RESULT OF HEREDITY, TRAUMA, OR DISEASES OF A JOINT. THE RAPID AND IRREGULAR GROWTH OF BONE OFTEN CAUSES A SHARP OR JUTTED STRUCTURE TO FORM, CAUSING PAIN AND IRRITATION TO THE SURROUNDING TISSUES. THE ONLY TREATMENT IS SURGICAL EXCISION OR SHAVING DOWN TO SMOOTH OUT THE EXCESS BONE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. 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 REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT ANKLE FUSION. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN WITH OSSIFICATION AND IMPINGEMENT. THE IMPLANTS REMAIN IMPLANTED AND THE PATIENT IS AWAITING A REVISION SURGICAL PROCEDURE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947329 TIBIAL INSERT COMPONENT SIZE 5 GREEN PLUS (+) 0 MM THICKNESS ANKLE PROTHESIS/EXTREMITIES NTG ZIMMER BIOMET, INC. N/A 62998251

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Hospitalization| R SEE H10 NARRATIVE