BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CEMENT

    MDR report key: 9860540 · Received March 20, 2020

    Report

    Report Number
    0001825034-2020-01240
    Event Type
    Injury
    Date Received
    March 20, 2020
    Date of Event
    November 22, 2019
    Report Date
    May 19, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#:141235; BIOMET CC CRUCIATE TRAY 79MM MM; LOT#:UNKNOWN, ITEM#:183666; VNGD PS TIB BRG 16X79/83MM MM; LOT#:UNKNOWN, ITEM#:184793;  SERIES A ASYMMETRIC PAT 34X8.5; LOT#:UNKNOWN, ITEM#:UNKNOWN; UNKNOWN FEMORAL COMPONENT; LOT#:UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS PLACED ON A 10 DAY HOLD AND RELEASED TO THE PATIENT. THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2020-01237, 0001825034-2020-01238, 0001825034-2020-01239. 0001825034-2020-01241. MW5092836

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TWO YEARS POST-OP DUE TO PAIN, INSTABILITY, LOOSENING AND IMPLANT WEAR. OFFICE NOTES INDICATED THE LOOSENING MAY HAVE BEEN CAUSED BY A METAL ALLERGY. ADDITIONALLY, THE PATIENT IS AMBULATORY WITH A CANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322355 UNKNOWN CEMENT BONE CEMENT LOD ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R