BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM POSTERIOR STABILIZED MONOBLOCK TIBIAL COMPONENT

    MDR report key: 6370208 · Received March 1, 2017

    Report

    Report Number
    3005751028-2017-00012
    Event Type
    Injury
    Date Received
    March 1, 2017
    Report Date
    May 15, 2017
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    PK020295
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE OPERATIVE NOTES, IMAGING REPORTS AND POST-OP VISIT NOTES. THE RIGHT KNEE TKA OCCURRED ON (B)(6) 2015. THE POLY PATELLA (NOT THE SUBJECT OF THIS INVESTIGATION) WAS REPORTED TO BE LOOSE AND THE TIBIAL ALIGNMENT WAS FOUND TO BE QUESTIONABLE ON (B)(6) 2016 (18 MONTHS POST-OP). BOTH COMPONENTS REMAIN IMPLANTED. IMAGING REPORT FROM THE LATEST X-RAY SERIES DATED (B)(6) 2016 REPORTED A STABLE APPEARANCE OF A RIGHT TKA WITH NO OBVIOUS EVIDENCE OF LOOSENING AROUND THE ARTHROPLASTY; HOWEVER, THE SURGEON'S OPINION IS THAT THE POLY PATELLA WAS LOOSE. THIS INVESTIGATION FINDS NO EVIDENCE THAT THE TM LPS MONOBLOCK TIBIA FAILED OR IS FAILING TO PERFORM AS INTENDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION MAY BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMPLANT'S MANUFACTURING RECORD INDICATES THAT IT WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BE OBTAINED TO FURTHER THIS INVESTIGATION, THIS REPORT SHALL BE UPDATED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    MEDICAL RECORDS INDICATED THAT THE PATIENT ALLEGED TO RIGHT KNEE PAIN, SWELLING, AND ERYTHEMA OVER THE WOUND. PATIENT HAS A HISTORY OF HYPERTENSION, DYSLIPIDEMIA, MORBID OBESITY AND TRICOMPARTMENTAL OSTEOARTHRITIS. PATIENT ALLEGED TO RIGHT KNEE PAIN, SWELLING, DISCOLORATION AND LOOSENING APPROXIMATELY ONE YEAR POST-IMPLANTATION. PLANNED REVISION IS UNKNOWN. THE TM MONBLOCK TIBIA IS THE ONLY COMPONENT WITH ZIMMER BIOMET-TMT DESIGN CONTROL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153433 TM POSTERIOR STABILIZED MONOBLOCK TIBIAL COMPONENT TM MONOBLOCK TIBIA JWH ZIMMER TMT N/A 61844337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention