BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 4, 11MM

    MDR report key: 19662084 · Received July 2, 2024

    Report

    Report Number
    1038671-2024-02288
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 27, 2024
    Report Date
    February 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174451
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 5595655 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 5886816 200-02-38 - THREE PEG PATELLA 38MM 5967719 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 5739495 201-78-81 - 3 TROCAR, MOD. HEX 2PK 5776117 201-78-81 - 3 TROCAR, MOD. HEX 2PK 5776129 201-78-81 - 3 TROCAR, MOD. HEX 2PK 323871 203-96-40 - (11-3661) STRYKER SYS 6 90X25X1.27 332364 203-96-42 - (11-3671) STRYKER SYS 6 90X13/21X1.19 S017519 521-78-23 - THREADED PIN SIZE 2.3 COLLARED S020256 521-78-23 - THREADED PIN SIZE 2.3 COLLARED S014713 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 03021019030 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. D10 CONCOMITANTS: (B)(6) 02-010-04-0240 - LOGIC CR FEMORAL POR, LEFT, SZ 4. (B)(6) 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. (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) 203-96-40 - (11-3661) STRYKER SYS 6 90X25X1.27. (B)(6) 203-96-42 - (11-3671) STRYKER SYS 6 90X13/21X1.19. (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. (B)(6) A10012 - GPS IMPLANT KIT V2. MOST-LIKELY UNDERLYING CAUSE: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, PAIN, AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REASON FOR THE PAIN COULD NOT BE DETERMINED. ADDITIONALLY, PROSTHESIS WEAR COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS 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

    CORRECTED INFORMATION: H6: HEALTH EFFECT-CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE. ADDITIONAL INFORMATION: H3: ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2019. APPROXIMATELY 4 YEARS AND 11 MONTHS LATER, ON (B)(6) 2024, THE PATIENT WAS REVISED. IT WAS REPORTED THAT THE ¿PATIENT PRESENTED TO [THE SURGEON] WITH A SORE KNEE. [THE SURGEON] DEALT WITH THE KNEE WITH SUSPICION DUE TO THE PREVIOUS TGA NOTIFICATIONS AND ONGOING ISSUE WITH THE KNEE INSERTS. [THE SURGEON] DECIDED TO REMOVE ALL IMPLANTS AND REPLACE WITH [ANOTHER MANUFACTURER¿S] REVISION KNEE SYSTEM.¿ NO ADDITIONAL INFORMATION REGARDING THE EVENT COULD BE PROVIDED. BECAUSE THE SURGEON DECIDED TO REVISE THE COMPONENTS DUE TO THE RECALL, IT APPEARS THEY ARE ALLEGING WEAR OF THE POLYETHYLENE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. MOST-LIKELY UNDERLYING CAUSE: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, PAIN, AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REASON FOR THE PAIN COULD NOT BE DETERMINED. ADDITIONALLY, PROSTHESIS WEAR COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. H6: INVESTIGATION CODES.

    Description of Event or Problem · 0

    APPROXIMATELY 4 YEARS AND 11 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT, THE PATIENT PRESENTED WITH A SORE KNEE AND WAS REVISED. ALL IMPLANTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S KNEE SYSTEM. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF BY THE CUSTOMER. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507889 LOGIC CR TIB INSERT STD, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174451

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11.| SEE H11.