MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.D10 concomitants: (b)(6), 02-020-11-0230 - truliant ps cem fem ps cem left sz 3.(b)(6), 02-020-11-0330 - truliant ps cem fem ps cem right sz 3.(b)(6), 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t.(b)(6), 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t.(b)(6), 200-07-32 - advanced patella 32mm 3 peg implant.(b)(6), 200-07-32 - advanced patella 32mm 3 peg implant.
Event or Problem Description
As reported, approximately 4.5 years post initial right side tka, the 55 y/o female patient complaint of pain and had a revision due to recalled poly and loose femur.Patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos and x-ray received.The device is not available for evaluation due to recall hospital will not release implants.Concomitant products: - truliant tib imp ps insert sz 3 9mm (cat# 02-022-35-3009 / serial# (b)(6) - serial number not affected by recall) complaint investigation findings: complaint investigation findings: the revisions reported in (b)(4) was likely the result of insufficient bonds between the femoral components and the bones and/or patient related conditions, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not returned for evaluation.The most probable root cause associated with the reported event of ¿loosening - femoral¿ is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.Ebi initial surgery attached.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 54 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear and pain.No further issues or complications were reported.No additional information is available.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3 9MM
• 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: 21243890
• Report Number: 1038671-2025-00433
• Device Sequence Number: 17039133
• Product Code: JWH
• UDI-Device Identifier: 10885862304254
• UDI-Public: 10885862304254
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-35-3009
• Device Lot Number: TRULIANT TIB IMP PS INSERT SZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/13/2025
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female