BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/RD/DOME PAT 3PEG,38

    MDR report key: 13111345 · Received December 29, 2021

    Report

    Report Number
    1818910-2021-28947
    Event Type
    Injury
    Date Received
    December 29, 2021
    Date of Event
    October 20, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232681
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 · 0

    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.

    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.

    Description of Event or Problem · 0

    CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS POLYETHYLENE WEAR. DATE OF IMPLANTATION: (B)(6) 2002; DATE OF REVISION: (B)(6) 2021; (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT AND PATELLA COMPONENTS. PRODUCT DETAILS: CATALOG: 129434130 , LOT: U4FER1007, DESCRIPTION: MBT POROCOAT KEEL SZ 3. CATALOG: 960053 , LOT: 286624, DESCRIPTION: SIGMA FEM POST/STAB CEMENTED RT SZ 3. CATALOG: 960112 , LOT: 1022501, DESCRIPTION: SIGMA PATELLA ROUND DOME 3 PEGGED 38.0MM. CATALOG: 962131 , LOT: 77005A, DESCRIPTION: SIGMA TIBIAL INSERT RP POST/STAB SZ 3 10MM. CATALOG: 545033000 , LOT: V4CC94000, DESCRIPTION: ENDURANCE BONE CEMENT 40G. CATALOG: 545033000 , LOT: V4CC94000, DESCRIPTION: ENDURANCE BONE CEMENT 40G.

    Description of Event or Problem · 0

    REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN AND INSTABILITY. UPON ENTERING THE JOINT, SYNOVITIS WAS ENCOUNTERED AND REMOVED. THE TIBIAL INSERT AND PATELLA COMPONENTS WERE SIGNIFICANTLY WORN AND PIECES WERE FRACTURES OFF OF EACH. A COMPREHENSIVE LAVAGE WAS PERFORMED ¿ NO INDICATION OF ANY PIECES OF POLY BEING LEFT IN THE PATIENT. THE INSERT AND PATELLA COMPONENTS WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011899 PFC*SIGMA/RD/DOME PAT 3PEG,38 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US 96-0112 1022501 10603295232681

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention DEPUY 3 SYRINGEABLE CEMENT 40G| DEPUY 3 SYRINGEABLE CEMENT 40G| MBT POR KEEL TIB TRAY SZ3| PFC SIGMARP STB TB IN 3 10.0| PFC*SIGMA C/S NPOR FEM RT SZ 3