BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA STAB GVF INS 2.5 10MM

    MDR report key: 12569651 · Received October 4, 2021

    Report

    Report Number
    1818910-2021-21837
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 20, 2021
    Report Date
    September 20, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295064091
    PMA / PMN Number
    K033272
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: B5 AND D9. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: H3.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY : THE RECEIVED DEVICE WAS FORWARDED TO COMMERCIALIZED PRODUCT DEVELOPMENT FOR EVALUATION, AND VISUAL EXAMINATION CONFIRMED THE FB INSERT WOULD NOT BE ABLE TO BE ASSEMBLED WITH THE FB TIBIAL TRAY DUE TO THE DAMAGE SUSTAINED TO THE INSERT DURING INSERTION. THEREFORE THE SUSPECTED CAUSE IS TRACED TO THE USE OF THE DEVICE, HOWEVER A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. BASED ON THE INABILITY TO FIND ANY NC¿S AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION, IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THE FOLLOWING: 1. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS. 2. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? 3. WAS THE PRODUCT IMPLANTED USING DEPUY SYNTHES¿S ATTUNE FEMUR FIRST ANATOMIC ALIGNMENT SURGICAL TECHNIQUE (DSUS/JRC/0617/2179) OR THE ATTUNE ANATOMIC TIBIA BALANCED FEMUR SURGICAL TECHNIQUE (097081-180816 DSEM)? ANSWER: 1. NO. 2. NO. 3. NO.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIXED BEARING INSERT WOULD NOT IMPACT INTO TRAY. NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465443 SIGMA STAB GVF INS 2.5 10MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US 1581-22-010 D21021908 10603295064091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention