BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS / FINN TRANSVERSE PIN

    MDR report key: 7049534 · Received November 21, 2017

    Report

    Report Number
    0001825034-2017-10451
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 16, 2017
    Report Date
    January 31, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK031804
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS COMPRESS SHORT ANCHOR PLUG # 178560 LOT # 353940. COMPRESS SHORT ANTI ROTATION SPINDLE # 178370 LOT # 056150. COMPRESS / FINN TRANSVERSE PIN # 178532 LOT # 682920. COMPRESS TO GMRS ADAPTER # CP0000640 LOT # 882500. COMPRESS CENTERING SLEEVE # 178542 LOT # 299940. COMPRESS NUT CO-CR-MO ALLOY # 178512 LOT # 885860. COMPRESS COMPRESSION CAP # 178399 LOT. #131010. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-10449, 0001825034-2017-10450 AND 0001825034-2017-10452. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY 20 DAYS POST PREVIOUS REVISION KNEE SURGERY DUE TO FEMORAL BONE FRACTURE AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827425 COMPRESS / FINN TRANSVERSE PIN PROSTHESIS KNEE KRO ZIMMER BIOMET, INC. N/A 042110

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R