BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENII OVAL RES PAT DR GD 35MM

    MDR report key: 15294356 · Received August 25, 2022

    Report

    Report Number
    1020279-2022-03846
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    August 5, 2022
    Report Date
    September 21, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRY
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE IS FRACTURED IN TWO, RENDERING THE DEVICE INOPERATIVE. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE DO NOT HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. ASSESSMENT OF HISTORICAL ESCALATED CASES CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS DEVICE AND FAILURE MODE. A CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD BE CORROBORATED AS THE DEVICE IS FRACTURED IN TWO. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE PROBABLE CAUSES OF THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, THE PA HIT ON A GENESIS II OVAL RESECTION PATELLA DRILL GUIDE 35MM AND IT BROKE INTO TWO PIECES. SURGERY WAS RESUMED, WITHOUT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319049 GENII OVAL RES PAT DR GD 35MM PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY SMITH & NEPHEW, INC. 02LM07652

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown