BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14699565 · Received June 15, 2022

    Report

    Report Number
    1818910-2022-10974
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 9, 2022
    Report Date
    June 15, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232629
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ALL AVAILABLE X-RAY EVIDENCE WERE REVIEWED AND DOES NOT SHOWS AN IMPLANT FRACTURE, DISASSOCIATION OR ANY INDICATIVE RELATED TO A DEVICE NONCONFORMANCE. BASED ON THE INFORMATION PROVIDED AS EVIDENCE, A DEFECT OR MALFUNCTION CANNOT BE ESTABLISHED, THEREFORE THE ALLEGATION IS NOT CONFIRMED. DEPUY SYNTHESE CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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

    SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR FEELINGS OF POPPING AND INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2006. DATE OF EVENT: (B)(6) 2022. DATE OF REVISION: NOT SPECIFIED (RIGHT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT. DEPUY COMPONENTS: CATALOG ID: 129433140, LOT ID: 2145987, COMPONENT TYPE: TIBIAL, DESCRIPTION: MBT CEMENTED KEEL SZ 4. CATALOG ID: 960014, LOT ID: H526014A, COMPONENT TYPE: FEMORAL, DESCRIPTION: SIGMA FEM C/RET CEMENTED RT SZ 4. CATALOG ID: 960102, LOT ID: 2153738, COMPONENT TYPE: PATELLAR, DESCRIPTION: OVAL DOME PATELLA 3 PEG SZ 38. CATALOG ID: 962042, LOT ID: 2090051, COMPONENT TYPE: INSERT, DESCRIPTION: SIGMA TIBIAL INSERT RP CVD SZ 4 12.5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813955 PFC*SIGMA/OV/DOME PAT 3PEG,38 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US 96-0102 2153738 10603295232629

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention MBT CEMENTED KEEL SZ 4| OVAL DOME PATELLA 3 PEG SZ 38| PFC SIGMARP CV TB/IN S4 12.5| SIGMA FEM C/RET CEMENTED RT SZ 4| SIGMA TIBIAL INSERT RP CVD SZ 4