BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD ARTHRO 5 DEG LCK COLLAR

    MDR report key: 12391349 · Received August 31, 2021

    Report

    Report Number
    0001825034-2021-02546
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    August 7, 2021
    Report Date
    January 11, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00880304082984
    PMA / PMN Number
    K042409
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE CONNECTOR IS THE DEVICE THAT FRACTURED, NOT THE LOCKING COLLAR. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE CONNECTOR IS THE DEVICE THAT FRACTURED, NOT THE LOCKING COLLAR. THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CP260608 - MOD ARTHRO NL 3CM ELIP CNCTR - 871510. CP260608 - MOD ARTHRO NL 3CM ELIP CNCTR - 871520. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS NOT RETURNED BY THE HOSPITAL. 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: 0001825034-2021-02547.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY BECAUSE THE OSS ARTHRODESIS CONNECTOR / COUPLER BROKE. X-RAYS ALSO SHOW A CORTICAL FRACTURE OF THE DISTAL FEMUR. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298430 MOD ARTHRO 5 DEG LCK COLLAR PROSTHESIS, KNEE HSB ZIMMER BIOMET, INC. N/A 658250 00880304082984

    Patients

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