BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN POLY SCREW

    MDR report key: 12082821 · Received June 29, 2021

    Report

    Report Number
    0001822565-2021-01755
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    April 11, 2021
    Report Date
    July 26, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00599403214 - ARTICULAR SURFACE WITH LOCKING SCREW SIZE STRIPED YELLOW/E F 14 MM HEIGHT - 62980817. 00598801013 - STEM EXTENSION STRAIGHT 13MM DIA X 100MM LENGTH(COMBINED LENGTH 145MM) - 63289863. 00598801012 - STEM EXTENSION STRAIGHT 12MM DIA X 100MM LENGTH(COMBINED LENGTH 145MM) - 62740824. 00599401592 - FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT - 63408845. 00598003702 - STEMMED TIBIAL COMPONENT PRECOAT SIZE 4 FOR CEMENTED USE ONLY USE OF THIS. TIBIAL COMPONENT WITH LCCK ARTICULATING SURFACES REQUIRES USING A STEM EXTEN - 63465701 66022663 - PALACOS R + G (1X40) - 85094551. FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001822565-2021-01287-2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A POLY EXCHANGE APPROXIMATELY 4 YEARS LATER DUE TO PAIN, WEAKNESS, A CLICKING SOUND, AND A LOOSE SCREW NOTED ON X-RAY. DURING THE REVISION IT WAS NOTED THAT THE POLY SCREW WAS BROKEN DUE TO METAL FATIGUE, SCREW AND POLY EXCHANGE WITHOUT COMPLICATION. THERE WAS NO TRAUMA TO THE LEG OR FALLS. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980194 UNKNOWN POLY SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R