BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEMMED TIBIAL COMPONENT PRECOAT SIZE 4

    MDR report key: 16854706 · Received May 2, 2023

    Report

    Report Number
    0002648920-2023-00082
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 5, 2023
    Report Date
    August 10, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    UDI-DI
    00889024217584
    PMA / PMN Number
    K173057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A2: YEAR OF BIRTH: 1964. D6A: EXACT IMPLANTATION DATE IS UNKNOWN BUT OCCURRED IN 2017. D10: UNKNOWN FEMORAL COMPONENT: CATALOG#NI, LOT #NI; UNKNOWN ARTICULAR SURFACE: CATALOG#NI; LOT#NI. G2: FOREIGN: GERMANY USER FACILITY: BFARM USER REPORT REFERENCE: 10211/23 DILIGENCE IS IN PROCESS TO DETERMINE WHETHER THE PRODUCT IS AVAILABLE FOR EVALUATION. THE INVESTIGATION IS IN PROGRESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT : SEE H10 NARRATIVE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED A BROKEN ARTICULAR SURFACE AND A BROKEN TIBIAL PLATE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PRE-OP DIAGNOSIS OF FRACTURED TIBIAL COMPONENT, PATIENT NOTED PAIN AND INSTABILITY, EXCISION OF SCAR TISSUE, MEDIAL PLATEAU WAS SUNK ABOUT 1 CM, A DRAIN WAS PLACED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FRACTURE OF HYPER-DENSE MATERIAL ALONG THE MEDIAL TIBIAL PLATEAU, NO BONY JOINT FRACTURE. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS COMPLAINT WAS CONFIRMED BY THE PICTURES OF THE EXPLANTED ITEMS BEING FRACTURED, THE MEDICAL RECORDS, AND THE X-RAY IMAGES. 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. D10: ARTICULAR SURFACE REGULAR CONSTRAINT SIZE YELLOW/C-H 10 MM HEIGHT: CATALOG# 90597003010, LOT#63667284; FEMORAL COMPONENT PRECOAT SIZE E LEFT: CATALOG#00595001501, LOT#63636144; PALACOS R+G 2X20: CATALOG#66017775, LOT#85785278, (B)(4); PALACOS R+G 2X40: CATALOG#6017747, LOT#86324612. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001822565-2023-01476. THE INVESTIGATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A COMPETENT AUTHORITY USER REPORT THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, SIX (6) YEARS POST-IMPLANTATION, THE PATIENT EXPERIENCED A FRACTURE OF THE TIBIAL COMPONENT. A REVISION SURGERY WAS PERFORMED IN WHICH THE COMPLETE PROSTHESIS SYSTEM WAS REPLACED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A COMPETENT AUTHORITY USER REPORT THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, SIX (6) YEARS POST-IMPLANTATION, THE PATIENT EXPERIENCED A FRACTURE, PAIN, AND INSTABILITY. DURING THE REVISION SURGERY FRACTURE OF THE TIBIAL COMPONENT AND ARTICULAR SURFACE WERE NOTED AS WELL AS SCAR TISSUE AND TIBIAL PLATEAU SUBSIDENCE WITHOUT LOOSENING. A REVISION SURGERY WAS PERFORMED IN WHICH THE COMPLETE PROSTHESIS SYSTEM WAS REPLACED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE HOWEVER IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711272 STEMMED TIBIAL COMPONENT PRECOAT SIZE 4 PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. 5980-37-02 63609055 00889024217584

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R SEE H10 NARRATIVE.| SEE H10 NARRATIVE.