BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20229305 · Received September 16, 2024

    Report

    Report Number
    1038671-2024-03541
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    November 21, 2023
    Report Date
    October 17, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159182
    PMA / PMN Number
    K111400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL; 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

    D4: ADDED CATALOG NUMBER, EXPIRATION DATE, SERIAL NUMBER, AND UDI. D6A/6B: ADDED SURGERY DATES. D10: 2119928 02-012-48-2509 - LOGIC CR TIB INSERT SLOPE +, SZ 2.5, 9 MM, 3628037 02-010-04-0325 - LOGIC CR FEMORAL POR, RIGHT, SZ 2.5, 4278313 200-02-29 - THREE PEG PATELLA 29MM, 4408314 02-012-45-2515 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T, 4693811 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE, 4707972 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 5W363 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19. G3: ADDED 510K NUMBER. H4: ADDED DEVICE MANUFACTURE DATE. H6: CORRECTED HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION BUT MAY HAVE BEEN REPORTED AT THIS LATER TIME DUE TO INCLUSION OF ONE OF THE IMPLANTED DEVICES IN THE PACKAGING RECALL. BASED ON LENGTH OF IMPLANTATION, THE REASON FOR REVISION APPEARS UNLIKELY TO BE SECONDARY TO PROSTHESIS WEAR. HOWEVER, THE REPORTED PROSTHESIS WEAR/FAILURE COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS NO IMAGES OR RADIOGRAPHS WERE PROVIDED, RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED, AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454549 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862159182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.| UNK.