BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC KNEE COMPONENTS

    MDR report key: 20688184 · Received November 14, 2024

    Report

    Report Number
    1038671-2024-04394
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 25, 2024
    Report Date
    January 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D8 THE FOLLOWING SECTIONS WERE CORRECTED: B2 D1 D4: CATALOG, SERIAL NUMBER, UDI AND EXPIRATION DATE UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED D10 CONCOMITANTS: (B)(6), 02-012-48-3511 - LOGIC TIBIAL INSERT SLOPE +, SZ 3.5, 11 MM, (B)(6), 02-010-04-0335 - LOGIC CR FEMORAL POR, RIGHT, SZ 3.5, (B)(6), 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T, (B)(6),200-02-38 - THREE PEG PATELLA 38MM, (B)(6), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, (B)(6), 201-78-81 - 3 TROCAR, MOD. HEX 2PK, (B)(6), 201-78-81 - 3 TROCAR, MOD. HEX 2PK, (B)(6), 201-78-81 - 3 TROCAR, MOD. HEX 2PK, (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, (B)(6), 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS. G4: 510K UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED. H4: MANUFACTURE DATE UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED H6. THE REASON FOR THE REVISION REPORTED MAY BE DUE TO PAIN, AS STATED IN THE EXPERIENCE REPORT. HOWEVER, THE REASON FOR THE PAIN COULD NOT BE DETERMINED, AND CONTRIBUTIONS FROM USER OR PATIENT RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, RADIOGRAPHS, OR COMPLETE DEVICES IMAGES WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANTS: 5107493- 02-010-04-0335 - LOGIC CR FEMORAL POR, RIGHT, SZ 3.5, 5099451- 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T, 5100478- 200-02-38 - THREE PEG PATELLA 38MM, 4578582- 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 5162872- 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 5192124- 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 5249188 -201-78-81 - 3 TROCAR, MOD. HEX 2PK, 5175947- 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, 5175981- 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, 4007444- 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6 YEARS AND 8 MONTHS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT PRESENTED WITH PAIN AND IT WAS DETERMINED THAT THE KNEE WAS PART OF THE RECALL. ALL IMPLANTS WERE REMOVED AND REPLACED WITH REVISION COMPETITOR IMPLANTS. THE EVENT WAS NOT RELATED TO BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186351 OPTETRAK LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11| SEE H11