BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

    MDR report key: 17851976 · Received October 2, 2023

    Report

    Report Number
    1038671-2023-02422
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    February 23, 2017
    Report Date
    October 16, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173638
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D1: CORRECTED D4: CORRECTED D10: CONCOMITANT DEVICES 2295720- 204-34-08 - FLUTED STEM EXTENSION 80L X 14 MM, 4019709 -201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 4092438 -200-02-32 - THREE PEG PATELLA 32MM, 4123344 -02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4, 4131980- 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T, 4139973- 204-70-00 - TIBIAL STEM EXT. SCREW, 4144296- 201-78-81 - 3" TROCAR, MOD. HEX 2PK, 4144335- 201-78-81 - 3" TROCAR, MOD. HEX 2PK, 53217 -203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19, 54075- 203-96-40 - (11-3973) STRYKER SYS 6 90X25X1.27. G4: CORRECTED H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, INSTABILITY AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR, INSTABILITY AND FEMORAL LOOSENING COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF 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

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 1 YEAR AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2017. UPON INFORMATION AND BELIEF, THE PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, INSTABILITY, AND COMPONENT LOOSENING. THE PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE WHICH LIMITED AND CONTINUES TO LIMIT HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003755 LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862173638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.| UNK.