BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM

    MDR report key: 20076197 · Received August 27, 2024

    Report

    Report Number
    1038671-2024-03110
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    August 30, 2022
    Report Date
    September 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173584
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 310542 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19 4781331 02-012-50-3011 - TRU TIB AUG 1/2 SIZE 3, 5MM 4858587 02-010-06-0330 - TRU CC FEMORAL SIZE 3 RIGHT 4871541 02-010-06-0531 - TRU POST. AUG. SIZE 3, 5MM 4884805 02-012-50-3011 - TRU TIB AUG 1/2 SIZE 3, 5MM 4890195 02-012-60-1480 - TRU STEM EXT 14MM X 80MM 5034397 02-012-60-1280 - TRU STEM EXT 12MM X 80MM 5147217 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM 5147222 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM 5196591 204-70-00 - TIBIAL STEM EXT. SCREW 5216191 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F/3T 5390101 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK 5461761 201-78-81 - 3" TROCAR, MOD. HEX 2PK AB3292 13A2101 - CEMEX SYSTEM FAST GENTA 70G. 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. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, AND INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR, AND INSTABILITY 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 51 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968958 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862173584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R