BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PLI XLK INS 2.5 12.5MM

    MDR report key: 12027350 · Received June 18, 2021

    Report

    Report Number
    1818910-2021-13055
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    June 5, 2021
    Report Date
    June 9, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295062448
    PMA / PMN Number
    K082500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. 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.

    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

    SUBJECT ID: (B)(4). STUDY: (B)(4). CLINICAL NOTIFICATION RECEIVED FOR REVISION TO ADDRESS INFECTION DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION: (B)(6) 2021. (RIGHT KNEE) TREATMENT: REVISION, REMOVAL OF ALL IMPLANTS, WITH PLACEMENT OF AN ANTIBIOTIC SPACER PRODUCT DETAILS: CATALOG: 158102112. LOT: 8943702. DESCRIPTION: SIGMA BANNISTER P/LIPPED XLK INSERT 2.5 12.5MM. CATALOG: 960018. LOT: D18102253. DESCRIPTION: SIGMA FEM C/RET CEMENTED RT SZ 2.5. CATALOG: 158125000. LOT: 9472648. DESCRIPTION: SIGMA BANNISTER TIBIAL TRAY CEMENTED SZ 2.5. CATALOG: 3312040. LOT: 9282835. DESCRIPTION: SMART SET CMW 1 40G. CATALOG: 3312040. LOT: 9282835. DESCRIPTION: SMART SET CMW 1 40G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922224 SIGMA PLI XLK INS 2.5 12.5MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US 1581-02-112 8943702 10603295062448

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention DEPUY CMW 1 40G| DEPUY CMW 1 40G| PFC*SIGMA C/R NPOR FE RT SZ2.5| SIG MOD TIB TRAY CEM COCR 2.5| SIGMA PLI XLK INS 2.5 12.5MM