BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3

    MDR report key: 6300183 · Received February 3, 2017

    Report

    Report Number
    0001822565-2017-00545
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    February 1, 2016
    Report Date
    October 30, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    PMA / PMN Number
    PK033363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED THROUGH RECEIPT OF MRI REPORT. PRODUCT WAS NOT RETURNED FOR EVALUATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: DATE RECEIVED BY MFR - INITIAL ( JAN. 3, 2017).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. BRAND NAME - TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3. COMMON DEVICE NAME - HSX. MODEL #/LOT # ¿ CATALOG 00584200302 LOT 62802366, EXP AUG 31, 2024. IMPLANT DATE ¿ (B)(6) 2014. CONCOMITANT MEDICAL PRODUCTS ¿ (B)(6) 2016. DATE RECEIVED BY MFR. - JUN 27, 2017. PMA - K033363. DEVICE MANUFACTURE DATE - SEP 15, 2014. (B)(4). CONCOMITANT MEDICAL PRODUCTS- FEMORAL COMPONENT CATALOG 00584201402 LOT 62761646; ARTICULAR SURFACE SIZE 3 9 MM HEIGHT CATALOG 00584209309 LOT 62482647.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AFTER A KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83124 TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3 PROSTHESIS, KNEE HSX ZIMMER, INC. N/A 62802366

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention