BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD ARTHRO 5 DEG LCK COLLAR

    MDR report key: 11949421 · Received June 7, 2021

    Report

    Report Number
    0001825034-2021-01674
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 10, 2021
    Report Date
    February 23, 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
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D9; G3; G6; H1; H2; H3; H6. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND 2 OF THE 4 SMALL LOCKING COLLAR BOLTS HAVE FRACTURED AT THE BASE OF THE THREADS. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED THE BOLT FRACTURE SURFACE SHOWED SHEARED DUCTILE OVERLOAD DIMPLES, INDICATING SHEAR OVERLOAD MODE OF FRACTURE. EDS SEMI-QUANTITATIVE ELEMENTAL ANALYSIS OF THE COLLAR BOLT SAMPLE SHOWED THAT THE MATERIAL IS CONFORMING. VISUAL EXAMINATION OF THE PROVIDE PHOTOGRAPH FOUND ONE OF THE SCREWS BACKED OUT AND WAS FLOATING IN THE JOINT SPACE. 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

    VISUAL EXAMINATION OF THE PROVIDE PHOTOGRAPHS CONFIRMS THAT 2 OFF THE SMALL SCREWS HAVE FRACTURED AND ONE OF THE SCREWS HAS BACKED OUT AND WAS FLOATING IN THE JOINT SPACE. THE DEVICE WAS NOT RETURNED FOR FURTHER EVALUATION. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY ONE YEAR LATER, THE PATIENT COMPLAINED OF PAIN AND INSTABILITY IN THE KNEE. SUBSEQUENTLY, THE PATIENT WAS REVISED 1.5 YEARS POST-IMPLANTATION DUE TO PAIN AND INSTABILITY. IT WAS DISCOVERED DURING SURGERY THAT SOME OF THE SCREWS WERE LOOSE AND THERE WAS A SCREW FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845962 MOD ARTHRO 5 DEG LCK COLLAR PROSTHESIS, KNEE HSB ZIMMER BIOMET, INC. N/A 658250 00880304082984

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R