MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Catalog Number	02-022-47-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a male patient, who had initial right knee implanted with recalled poly on (b)(6) 2019, was revised to a logic cc system on (b)(6) 2022, approximately 3 years 2 months post the initial implant procedure due to wear.Patient was last known to be in stable condition following the event.The device is available for return.No other patient information/medical history provided.
Additional Manufacturer Narrative
H6: the reason for the full knee revision reported cannot be determined as limited information was provided and only the tibial insert was returned for evaluation but was likely the result of loosening, infection, fracture, instability, or patient related factors.While it cannot be confirmed if the polyethylene component was included in the packaging recall as reported, the reason for revision does not appear to be related to wear of the tibial insert as the returned implant appears unremarkable.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 4, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15413610
• Report Number: 1038671-2022-01101
• Device Sequence Number: 12175458
• Product Code: JWH
• UDI-Device Identifier: 10885862306470
• UDI-Public: 10885862306470
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-47-4009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2022
• Supplement Date Received by Manufacturer: 11/01/2022; 08/12/2026
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/29/2022; 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male