BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 2, 13MM

    MDR report key: 19383597 · Received May 23, 2024

    Report

    Report Number
    1038671-2024-01434
    Event Type
    Injury
    Date Received
    May 23, 2024
    Report Date
    March 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048240
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: (B)(6), 234-02-04 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4, (B)(6), 204-38-08 - STEM EXTENSION 80L X18 MM, (B)(6), 208-01-04 - CC FEMORAL SZ 4, (B)(6), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, (B)(6), 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE, (B)(6), 201-78-88 - 4"" DRILL BIT, MOD. HEX 2-PK, (B)(6), 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T, (B)(6), 200-02-38 - THREE PEG PATELLA 38MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND LOOSENING AND/OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    THE PATIENT HAS FILED A LONG-FORM COMPLAINT IN THE CIRCUIT COURT OF THE EIGHT JUDICIAL CIRCUIT IN AND FOR (B)(6). THE PATIENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE NATURE OF THE IMPLANT WHICH NECESSITATED PREMATURE REMOVAL, THE PATIENT SUFFERED SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, MENTAL AND EMOTIONAL DISTRESS. PER THE INFORMATION AVAILABLE IN THE LEGAL DOCUMENTATION PROVIDED, THE PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANATION OF THE LEFT KNEE AT ISSUE. THE PATIENT HAS HAD A RIGHT KNEE REVISION (B)(6) THAT IS ALSO COVERED IN THIS LEGAL LONGFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980377 PS TIBIAL INSERTS SZ 2, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862048240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10