BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC SIGMA CVD INSRT SZ2.5 10MM

    MDR report key: 17446668 · Received August 2, 2023

    Report

    Report Number
    1818910-2023-15802
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Report Date
    August 2, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: OKAZAKI Y, HOSOBA M, MIURA S, MOCHIZUKI T. EFFECTS OF KNEE SIMULATOR CONTROL METHOD AND RADIATION DOSE ON UHMWPE WEAR RATE, AND RELATIONSHIP BETWEEN WEAR RATE AND CLINICAL REVISION RATE IN NATIONAL JOINT REGISTRY. J MECH BEHAV BIOMED MATER. 2019 FEB;90:182-190. DOI: 10.1016/J.JMBBM.2018.09.034. EPUB 2018 OCT 1. PMID: 30368204. THE WEAR RATE OF FIVE TYPES OF CRUCIATE-RETAINING ARTIFICIAL KNEE JOINT ULTRAHIGH-MOLECULAR-WEIGHT POLYETHYLENE (UHMWPE) INSERTS WAS EXAMINED USING TWO CUSTOM-MADE KNEE JOINT SIMULATORS SATISFYING ISO 14243¿1 (LOAD CONTROL) AND ISO 14243¿3 (DISPLACEMENT CONTROL). THE WEAR RATE OF KNEE JOINTS COMPOSED OF A UHMWPE INSERT AND A CO-CR-MO ALLOY OR OXIDIZED ZIRCONIUM FEMORAL COMPONENT LINEARLY INCREASED WITH INCREASING NUMBER OF WEAR CYCLES, AND THE VOLUMETRIC WEAR RATE PER MILLION CYCLES WAS APPROXIMATELY 6¿18 MM3 /MC. 6 SETS OF DEPUY KNEE PRODUCTS WAS TESTED IN THIS EXPERIMENT ALONG WITH VARIOUS COMPETITOR KNEES PFC SIGMA CR POROUS, SIZE 2.5, CO-CR-MO, (96-0028). PFC SIGMA CVD, SIZE 2.5, 10 MM, GUR402 UHMWPE, CURVED (96-0341), PFC SIGMA KEEL, POROUS SIZE 2.5, TI-6AL-4V (86-4179) THIS STUDY ALSO ANALYZED THE EFFECT OF IN VIVO WEAR ON CLINICAL REVISION RATE IN NATIONAL JOINT REGISTRY. THE WEAR RATES OBTAINED USING VARIOUS TYPES OF SIMULATOR FOR THE FOLLOWING 16 ARTIFICIAL KNEE JOINTS HAVE BEEN REPORTED IN THE LITERATURE. TWO OF THOSE JOINTS CONTAINED DEPUY KNEES. LCS CR MBT (7.0 ± 1.8 MM3 /MC, CPE) AND PFC SIGMA CR MBT (8.5 ± 4.0 MM3/MC, CPE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285213 PFC SIGMA CVD INSRT SZ2.5 10MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT HAW DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown