BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,35

    MDR report key: 10816220 · Received November 10, 2020

    Report

    Report Number
    1818910-2020-24290
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 26, 2020
    Report Date
    October 26, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232612
    PMA / PMN Number
    K961685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. 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 ==> EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. NO EVIDENCE WAS FOUND OF PRODUCT MALFUNCTION OR PRODUCT ERROR WAS IDENTIFIED. THE NEED FOR CORRECTIVE ACTION IS NOT ESTABLISHED AT THIS TIME. 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 ==> PRODUCT CODE 960101, WORK ORDER 8703345 WAS MANUFACTURED ON 03 JAN 2018. (B)(4) WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. EXPIRY DATE 2022-12-31 THERE WAS ONE NC¿S ASSOCIATED WITH THIS BATCH, NR-0115853, IN RELATION TO AN INCORRECT TOOL USED IN MACHINE LTHE0038. THE AFFECTED AREA OF THE PART FROM THE INCORRECT TOOL USED IS NOT A CRITICAL FEATURE, DOES NOT INTERACT WITH INSTRUMENTATION AND DOES NOT CONTACT OTHER IMPLANTS IN THE CONSTRUCT, THEREFORE, THIS NR DOES NOT CORRELATE WITH FAILURE MODE. THERE WAS ONE CAPA ASSOCIATED WITH THIS BATCH, CAPA(B)(4) IN RELATION TO THE NR REFERENCED ABOVE, NR-0115853, WHICH DOES NOT CORRELATE WITH FAILURE MODE. THERE WERE NO DEVIATIONS ASSOCIATED WITH THIS BATCH. DUE TO NO SIMILAR FAILURES FOUND IN THE DHR REVIEW, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. SHOULD FURTHER INFORMATION COME AVAILABLE THAT IMPACTS THE FINDINGS IN THIS INVESTIGATION IT WILL BE REOPENED. CORRECTED: H3

    Additional Manufacturer Narrative · 1

    (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 DURING A RIGHT TOTAL KNEE ARTHROPLASTY CASE, THEY ARRIVED AT THE POINT WHERE IMPLANTS WERE BEING PASSED TO THE SURGICAL STAFF ONTO THE STERILE FIELD BY THE CIRCULATING NURSE. AS THE SURGICAL STAFF WERE OPENING THE STERILE IMPLANTS TO PREPARE FOR IMPLANTATION, IT WAS NOTICED THAT UPON OPENING THE SIGMA PATELLA IMPLANT, THERE WAS A ROUGH SCRATCH/GOUGE ALONG THE TOP CIRCULAR EDGE OF THE IMPLANT. THIS WAS BROUGHT TO THE SALES REP ATTENTION IMMEDIATELY, AND THEY ADVISED THE SURGEON OF THE SAME. THE SURGICAL STAFF MEMBER PASSED THE IMPLANT OFF THE STERILE FIELD, AND SALES REP BROUGHT THE CIRCULATING NURSE ANOTHER PATELLA IMPLANT TO REPLACE THAT ONE. ONCE THE NEW ONE WAS PASSED ONTO THE STERILE FIELD, THE CASE CONTINUED WITHOUT INCIDENT. DOE: (B)(6) 2020, RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282778 PFC*SIGMA/OV/DOME PAT 3PEG,35 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US 96-0101 8703345 10603295232612

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR