BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 2, 18MM

    MDR report key: 13061569 · Received December 22, 2021

    Report

    Report Number
    1038671-2021-00731
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    December 1, 2021
    Report Date
    May 27, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054203
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: CC TIBIAL INSERT SZ 2, 18MM (CAT# 208-22-18 / SERIAL# (B)(4)); CC FEMORAL SZ 2 (CAT# 208-01-02 / SERIAL# (B)(4)); LOGIC STEM EXT 14MM X 160MM (CAT# 02-012-60-1416 / SERIAL# (B)(4)); THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G6, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. AS REPORTED, 59 YEARS OLD MALE PATIENT RETURNED WITH KNEE PAIN AND INSTABILITY. SALES REP. WAS ALERTED BY SURGEON¿S OFFICE THAT HE WANTED TO PERFORM A FEMORAL REVISION ON AN OPTETRAK CCK. DUE TO THE FACT THAT THERE WAS AN OFFSET TIBIA IN THE PATIENT IT WAS DECIDED THAT WE MUST USE THE OLD CCK. THE FEMORAL COMPONENT WAS REMOVED. THE FEMUR WAS RECUT AND 20MM DISTAL AUGMENTS WERE USED (UP FROM 15MM). STEM LENGTH WAS INCREASED FROM 120MM TO 160MM AND AN APPROPRIATE CCK INSERT, AND OFFSET SCREW WERE USED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. UPON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT A DESIGN OR MANUFACTURING ISSUE CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED REVISION WAS LIKELY THE RESULT OF UNDERLYING PATIENT FACTORS, WHICH LED TO INSTABILITY OF THE JOINT.

    Description of Event or Problem · 0

    AS REPORTED, (B)(6) YEARS OLD MALE PATIENT RETURNED WITH KNEE PAIN AND INSTABILITY. SALES REP. WAS ALERTED BY SURGEON¿S OFFICE THAT HE WANTED TO PERFORM A FEMORAL REVISION ON AN OPTETRAK CCK. DUE TO THE FACT THAT THERE WAS AN OFFSET TIBIA IN THE PATIENT AND IT WAS DECIDED TO USED THE OLD CCK. THE FEMORAL COMPONENT WAS REMOVED. THE FEMUR WAS RECUT AND 20MM DISTAL AUGMENTS WERE USED (UP FROM 15MM). STEM LENGTH WAS INCREASED FROM 120MM TO 160MM AND AN APPROPRIATE CCK INSERT, AND OFFSET SCREW WERE USED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966097 CC TIBIAL INSERT SZ 2, 18MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. CC TIBIAL INSERT SZ 2, 18MM UNK 10885862054203

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention