MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-47-3509
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Concomitants: (b)(6), 02-022-47-3509 - truliant tib imp cr ins std sz 3.5, 9 mm, (b)(6), 02-022-47-3509 - truliant tib imp cr ins std sz 3.5, 9 mm, (b)(6), 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t, (b)(6), 200-02-32 - three peg patella 32mm, (b)(6), 200-02-32 - three peg patella 32mm, (b)(6), 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t, (b)(6), 201-78-82 - collar fixation pin 2pk 40mm, quick release, (b)(6), 02-020-13-0335 - truliant cr cem fem cr cem right sz 3.5, (b)(6), 201-78-15 - holding pin mini sharp point 4 pk, (b)(6), 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
Correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2024-02760.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 19949925
• Report Number: 1038671-2024-02761
• Device Sequence Number: 21035347
• Product Code: JWH
• UDI-Device Identifier: 10885862306425
• UDI-Public: 10885862306425
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2025
• Device Catalogue Number: 02-022-47-3509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown