BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19949745 · Received August 9, 2024

    Report

    Report Number
    1038671-2024-02760
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    November 21, 2023
    Report Date
    August 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS FROM EBI: 4901526, 02-022-47-3509 - TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM. 4901542, 02-022-47-3509 - TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM. 5092342, 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F/3.5T. 5591823, 200-02-32 - THREE PEG PATELLA 32MM. 5617429, 200-02-32 - THREE PEG PATELLA 32MM. 5651311, 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F/2.5T. 5739963, 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE. 5750807, 02-020-13-0335 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5. 5774968, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 5792838, 02-020-13-0235 - TRULIANT CR CEM FEM CR CEM LEFT SZ 3.5. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0023-2022. 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 FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, D1/D2A/D2B, D4, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. B3: DATE OF EVENT IN UNKNOWN. THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS REPORTED IN ERROR. THIS REPORT IS IN REFERENCE TO A PATIENT WITH BILATERAL KNEE REPLACEMENTS. THE PATIENTS LEFT KNEE REPLACEMENT WAS PREVIOUSLY REPORTED UNDER REPORT #1038671-2023-02928. THE PATIENTS RIGHT KNEE REPLACEMENT WAS PREVIOUSLY REPORTED UNDER REPORT #1038671-2023-02929.

    Description of Event or Problem · 0

    LEGAL CASE: USA. LOR FORM RECEIVED IN COMPLAINT INBOX ON 06DEC2023. NO INFORMATION PROVIDED OTHER THAN PATIENT NAME. EBI DATA WAS IDENTIFIED BASED ON PATIENT'S NAME ONLY AND CASE UPDATED. NO INFORMATION ABOUT REVISION OR SURGERY OPS REPORTS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257840 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK.