BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG MOD TIB TRAY CEM COCR 2.5

    MDR report key: 15239860 · Received August 17, 2022

    Report

    Report Number
    1818910-2022-15975
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 17, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295064565
    PMA / PMN Number
    K032151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS RECEIVED FOR EXAMINATION. EXAMINATION FOUND THE INNER PLASTIC PACKAGE WARPED AND DEFORMED, THE DAMAGE OBSERVED CONFIRMED THE REPORTED ALLEGATION. THE DEVICE WAS SENT TO SUZHOU MFG SITE FOR FURTHER ANALYSIS. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: LOT NUMBER D22063382 MANUFACTURED ON 27-JUN-2022. 24 PCS PARTS MANUFACTURED PER SPECIFICATION. NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. EXPIRY DATE IS 31-MAY-2032. IFU REFERENCE NO. IS IFU-0902-00-886. DEVICE HISTORY REVIEW: LOT NUMBER D22063382 MANUFACTURED ON 27-JUN-2022. 24 PCS PARTS MANUFACTURED PER SPECIFICATION. NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. EXPIRY DATE IS 31-MAY-2032. IFU REFERENCE NO. IS IFU-0902-00-886. H10 ADDITIONAL NARRATIVE: ADDED: D10 CORRECTED: H3.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS RECEIVED FOR EXAMINATION. EXAMINATION FOUND THE INNER PLASTIC PACKAGE WARPED AND DEFORMED, THE DAMAGE OBSERVED CONFIRMED THE REPORTED ALLEGATION. THE DEVICE WAS SENT TO SUZHOU MFG SITE FOR FURTHER ANALYSIS. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: LOT NUMBER; D22063382 MANUFACTURED ON 27-JUN-2022. 24 PCS PARTS MANUFACTURED PER SPECIFICATION. NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. EXPIRY DATE IS 31-MAY-2032. IFU REFERENCE NO. IS IFU-0902-00-886.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 2.5 SIGMA TIBIAL TRAY WAS TRIED TO OPEN TO THE FIELD AND THE NURSE COULD NOT GET IT OUT FROM THE PACKAGING. A SECOND ONE WAS OPENED THAT HAD THE SAME LOT NUMBER AND THE SAME THING HAPPENED. IT WAS LIKE THAT THE PLASTIC PACKAGING HAD MELTED TOGETHER. THEY WERE IMPLANTS THAT ARRIVED THE DAY BEFORE. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510012 SIG MOD TIB TRAY CEM COCR 2.5 SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US 1581-25-000 D22063382 10603295064565

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female SIG MOD TIB TRAY CEM COCR 2.5.| SIG MOD TIB TRAY CEM COCR 2.5.| SIG MOD TIB TRAY CEM COCR 2.5.