BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 3 10.0

    MDR report key: 10245861 · Received July 8, 2020

    Report

    Report Number
    1818910-2020-15255
    Event Type
    Injury
    Date Received
    July 8, 2020
    Date of Event
    June 22, 2020
    Report Date
    June 22, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295241249
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H6 PATIENT CODE: NO CODE AVAILABLE (31910 WAS USED TO CAPTURE INSUFFICIENT INFORMATION AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY = THE RECEIVED DEVICE WAS FORWARDED TO COMMERCIALIZED PRODUCT DEVELOPMENT AT DEPUY WARSAW FOR EVALUATION. EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED DAMAGE. NO FURTHER INVESTIGATIONAL INFORMATION WAS PROVIDED TO CONFIRM THE REPORTED SPIN OUT. NO PRODUCT CONTRIBUTION TO THE REPORTED EVENT COULD BE IDENTIFIED BASED ON THE PROVIDED EVIDENCE. THE INVESTIGATION DID NOT ESTABLISH A NEED FOR CORRECTIVE ACTION. 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 = PRODUCT CODE 962131, WORK ORDER 1919240 WAS MANUFACTURED ON 10-JUN-2005. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WAS NO SCRAP PARTS ASSOCIATED WITH THIS LOT. THERE WAS NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. DEVINT-1020 IS ASSOCIATED WITH THIS LOT. ON REVIEW OF THE DEVIATION IT WAS FOUND THAT IT WAS RELATED TO THE INTRODUCTION OF A 100% INSPECTION TO BE PERFORMED ON ALL PACKAGED PRODUCTS AT DEPUY CORK. THEREFORE, THIS DEVIATION IS UNRELATED TO THE FAILURE MODE OF THIS PC.

    Description of Event or Problem · 0

    AFFECTED SIDE IS THE RIGHT.

    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

    PATIENT COMPLAINED OF POLY SPINNING OUT OF PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710211 PFC SIGMARP STB TB IN 3 10.0 SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US 96-2131 1919240 10603295241249

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention PFC SIGMARP STB TB IN 3 10.0| PFC SIGMARP STB TB IN 3 10.0