MAUDE Adverse Event Report: EXACTECH INC. TRULIANT TIB IMP PS INSERT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Unspecified Musculoskeletal problem (4535); Insufficient Information (4580)
Date of Event	12/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.There is no other information provided.
Event or Problem Description
It was reported via legal documentation that a patient had an initial left total knee arthroplasty on (b)(6) 2017, with no revision surgery reported.No other patient information/medical history reported.No radiographic images of the device are provided.No other information is available.
Additional Manufacturer Narrative
H10.D10.Concomitants - product information: 4894852 200-02-35 - three peg patella 35mm; 5129795 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t; 5165848 02-020-11-0240 - truliant ps cem fem ps cem left sz 4; 5168121 204-70-00 - tibial stem ext.Screw; 5174639 204-34-02 - fluted stem extension 25l x 14 mm.Updated/additional information ¿the prosthesis wear reported may have been the result of malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the extent and root cause of the reported polyethylene wear cannot be confirmed as the devices were not available for evaluation and radiographs/ photographs and operative notes were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6: impact code and type of investigation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3: removed erroneous entry, b5, e4: removed erroneous entry, g1, g2: consumer, h6: clinical code, component code, type of investigation, investigation findings.The prosthesis wear reported may have been the result of malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the extent and root cause of the reported polyethylene wear cannot be confirmed as the devices were not available for evaluation and radiographs/ photographs and operative notes were not provided.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 the patient underwent an initial left total knee arthroplasty.Subsequently, the patient reported experiencing pain, weakness, stiffness, discomfort, ambulation difficulties and prosthesis wear.No medical or surgical intervention was reported as a result of this event.No further information available.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18702238
• Report Number: 1038671-2024-00215
• Device Sequence Number: 20391606
• Product Code: JWH
• UDI-Device Identifier: 10885862304438
• UDI-Public: 10885862304438
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2025
• Device Catalogue Number: 02-022-35-4009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 04/18/2024; 01/26/2026; 02/10/2026
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 04/23/2024; 02/10/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• 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.; UNK.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown