MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS POR FEM PS POR LEFT SZ 3.5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED

Model Number	TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Unspecified Tissue Injury (4559); Aseptic loosening (4883)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2021.The patient complained of sever pain, a possible loose femur, and was revised to a competitor's product.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 6739119, 02-020-12-0235 - truliant ps por fem ps por left sz 3.5; 6030524, 02-022-55-3525 - truliant por tib tray size 3.5f/25t; ;6982635, 200-07-32 - advanced patella 32mm 3 peg implant.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening, osteolysis, and pain.However this cannot be confirmed as the devices were not returned for evaluation and pre-revision radiographs were unable to be obtained.H7: z-0023-2022.
Event or Problem Description
As reported, the patient had an initial left (b)(6).The patient complained of sever pain, a possible loose femur, and was revised to a competitor's product.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d8, f10 (remove data from initial), g1, h6: clinical code, component code, type of investigation, investigation findings, investigation conclusions.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT PS POR FEM PS POR LEFT SZ 3.5
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED
• 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 ; 3523771140
• MDR Report Key: 15419116
• Report Number: 1038671-2022-01112
• Device Sequence Number: 14789085
• Product Code: MBH
• UDI-Device Identifier: 10885862314796
• UDI-Public: 10885862314796
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026
• 2 Devices were Involved in the Event: 1 2

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 3.5 9MM
• Device Catalogue Number: 02-020-12-0235
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 03/14/2023; 02/05/2026
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 04/01/2023; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female