BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIALTRAY

    MDR report key: 13257894 · Received January 14, 2022

    Report

    Report Number
    0001822565-2022-00090
    Event Type
    Injury
    Date Received
    January 14, 2022
    Report Date
    January 20, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCT:S KNE-OTHER-FEMORALS UNK CATALOG #: N/I LOT #: N/I; KNE-OTHER-BEARINGS UNK CATALOG #: N/I LOT #: N/I; KNE-OTHERTIBIALTRAYS-UNK CATALOG #: N/I LOT #: N/I. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00088, 0001822565-2022-00089. INVESTIGATION INCOMPLETE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE RESULTS OF THE INVESTIGATION ARE AS FOLLOWS: NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : INSUFFICIENT PRODUCT INFORMATION.

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE PATIENT HAD A MEDIAL PARTIAL KNEE REPLACEMENT AND IS NOW HAVING PAIN AND SWELLING ON THE LATERAL SIDE OF THE KNEE AT THIS TIME AND ATTRIBUTES THE PAIN AND SWELLING TO THE LATERAL SIDE WITHOUT IMPLANTS, LIKELY DUE TO PRE-EXISTING OSTEOARTHRITIS. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL PARTIAL KNEE ARTHROPLASTY APPROXIMATELY 3 MONTHS AGO. SUBSEQUENTLY, PATIENT IS EXPERIENCING PAIN ON LATERAL SIDE AND HAS AFFECTED DAILY ACTIVITY. PATIENT HAS ALSO HAD BLOOD DRAINED FROM THE KNEE TWICE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE PATIENT HAD A MEDIAL PARTIAL KNEE REPLACEMENT AND IS NOW HAVING PAIN AND SWELLING ON THE LATERAL SIDE OF THE KNEE AT THIS TIME AND ATTRIBUTES THE PAIN AND SWELLING TO THE LATERAL SIDE WITHOUT IMPLANTS, LIKELY DUE TO PRE-EXISTING OSTEOARTHRITIS. THE INITIAL REPORT SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611069 UNKNOWN TIBIALTRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| R SEE H10 NARRATIVE.