BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC KEEL TIB TRAY CEM SZ3

    MDR report key: 11358122 · Received February 22, 2021

    Report

    Report Number
    1818910-2021-03511
    Event Type
    Injury
    Date Received
    February 22, 2021
    Date of Event
    February 4, 2021
    Report Date
    February 4, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295216438
    PMA / PMN Number
    K830927
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE 01-JAN-2015. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. DEVICE HISTORY LOT : PRODUCT CODE 864181 WORK ORDER (B)(4) WAS MANUFACTURED ON 27-JUN-2001. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE ARE NO SCRAP PARTS ASSOCIATED WITH LOT 928503. THE CMM REPORTS WERE REVIEWED AS PARTS OF THIS DHR REVIEW. ALL PARTS AT THE MACHINING STEP IN THE PROCESS ARE 100 PERCENT INSPECTED ON A CMM AND ALL PARTS PASSED THE CMM INSPECTION THEREFORE THERE IS NO CORRELATION TO THE FAILURE MODE DESCRIBED. DEVIATION 1067 FOUND ASSOCIATED WITH LOT 928503. THIS WAS OPENED TO DOCUMENT A CHANGE FOR MPS0555 TO CORRECT OVERLABEL PART THEREFORE THERE IS NO CORRELATION BETWEEN DEV. 1067 AND THE COMPLAINT FAILURE MODE.

    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

    REVISION TOTAL KNEE REPLACEMENT FOR LOOSENING AND INSTABILITY. PFC SIGMA PS FB TKR. NO IMPLANT DETAILS ARE AVAILABLE DUE TO RECORDS BE UNAVAILABLE DUE TO TIMEFRAME. THE ENTIRE TIBIAL COMPONENT WAS AFFECTED, NOT ONE PARTICULAR SIDE. THE KNEE WAS 20 YEARS OLD IT WAS HARD TO DETERMINE WHAT INTERFACE WAS INVOLVED. THIS WAS ASSOCIATED WITH BONE SUBSIDENCE AND COLLATERAL LIGAMENT INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255269 PFC KEEL TIB TRAY CEM SZ3 SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US 86-4181 928503 10603295216438

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PFC SIGMA STAB INS SZ3 15MM| PFC*SIGMA C/S NPOR FEM RT SZ 3| PFC*SIGMA/OV/DOME PAT 3PEG,38