MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	TRULIANT TIB IMP PS INSERT SZ 5 9MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526); Joint effusion (4849)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
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 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: 02-020-11-0250 - truliant ps cem fem ps cem left sz 5, (b)(6), 02-012-60-1425 - logic stem ext 14mm x 25mm, (b)(6), 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t, (b)(6), 200-07-32 - advanced patella 32mm 3 peg implant, (b)(6).
Event or Problem Description
Legal case ¿ usa (master case no.(b)(4), patient id: (b)(6), related (b)(4).Additional information received from legal on 25-sep-2023- 9 jan 2024, (b)(6), rn- implant date: on (b)(6) 2021, for osteoarthritis, morbid obesity/ bmi 46 (op report attached), explant date: on (b)(6) 2022, post operative diagnosis: failed left knee, secondary to aseptic loosening of the femoral component and recalled tibial insert.Patient transferred to recovery room in stable condition.(op report attached).The patient has filed a short-form complaint in a coordinated action in alachua county with master case no.(b)(4).Original description summary: additional information: legal short form received from legal on 20-jun-2023 legal case (b)(6).Implant date: on (b)(6) 2019 explant date: on (b)(6) 2023 no further information.Original description summary: experience report - usa.As reported, approximately 1.5 years post op the initial left tka, this 69 y/o male patient was revised due to a loose femur.Patient complained of pain.Due to recall surgeon used competitors implants.Patient was last known to be in stable condition following the event.Is the reported event associated with revision of exactech implants? yes provide the initial implant date (index surgery date) on (b)(6) 2021.Was the patient revised to exactech devices? no.Due to recall surgeon used competitors implants.Is the reported event related to the breakage of a device? no did the reported event lead to a surgical delay/prolongation? no images? yes.Attached x-rays? no.Patient id: (b)(6).
Additional Manufacturer Narrative
B4: corrected.
Event or Problem Description
As reported, approximately 1.5 years post op the initial left tka, this 69 y/o male patient was revised due to a loose femur.Patient complained of pain.Due to recall surgeon used competitors implants.Patient was last known to be in stable condition following the event.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 5 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: 21246921
• Report Number: 1038671-2025-00459
• Device Sequence Number: 15579662
• Product Code: JWH
• UDI-Device Identifier: 10885862304612
• UDI-Public: 10885862304612
• 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: 2021
• Device Explanted Year: 2022
• 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): 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 5 9MM
• Device Catalogue Number: 02-022-35-5009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/03/2025
• Date Device Manufactured: 08/24/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male