BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC SIGMA STAB INS SZ2 8MM

    MDR report key: 15954721 · Received December 9, 2022

    Report

    Report Number
    1818910-2022-24979
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 22, 2022
    Report Date
    December 9, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: TIBIAL INSERT WEAR REQUIRES REVISION SURGERY AND THE IN SITU IMPLANT IS OBSOLETE. A COMPLAINT IS REQUIRED TO ACCESS CONTINUING CARE IMPLANT PROVISION PRODUCT CODE: 96-0420, LOT/BATCH/EXP: 1106687. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? ONGOING, PATIENT SCHEDULED FOR REVISION SURGERY. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? NEED FOR REVISION (CAVEATED BY THE FACT THE IMPLANT HAS LASTED 19 YEARS). WAS THE SURGERY PROLONGED DUE TO THE EVENT? NA. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NA. IS THE PRODUCT AVAILABLE FOR RETURN? NO. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: PFC SIGMA KNEE IMPLANTED IN 2003 (PRE I2 LOCKING MECHANISM CHANGE). IMPLANT HAS LASTED WELL BUT THE TIBIAL INSERT NOW REQUIRES EXCHANGE. THE ONE IN SITU IS OBSOLETE AND SO ONE IS REQUIRED TO BE MADE THROUGH THE CONTINUING CARE PATHWAY, HENCE THE PRODUCT COMPLAINT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543150 PFC SIGMA STAB INS SZ2 8MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US 1106687

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown