MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-022-47-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t 5582121.02-020-13-0330 - truliant cr cem fem cr cem right sz 3 5123535.200-02-35 - three peg patella 35mm 6204629.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement on (b)(6) 2020.They had right knee revision surgery (b)(6) 2023, approximately 3 years 3 months after their initial procedure.Per (b)(6) 2023 op report: the patient had chronic pain in the knee.Based on x-rays, it was felt that the tibial component might be oversized, but at the time of surgery of the medial aspect of the tibial tray was clearly visualized and there was no overhang.The tibia appeared to be well-positioned and well sized.The tibial tray was closely inspected and found to be stable without any overhang on the medial tibial plateau.Postoperative diagnosis: sling wear, right total knee.The patient was awakened from anesthetic and taken to the recovery room in stable condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
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 reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to 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 and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: kate jacobson ; 3523782617
• MDR Report Key: 17232473
• Report Number: 1038671-2023-01509
• Device Sequence Number: 7241058
• Product Code: JWH
• UDI-Device Identifier: 10885862306371
• UDI-Public: 10885862306371
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 02-022-47-3009
• Device Catalogue Number: 02-022-47-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H11..
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female