MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 2.5, 11MM; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Model Number	02-022-44-2511
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Pending investigation.
Event or Problem Description
It was reported via legal documentation that a patient had and initial right knee arthroplasty on (b)(6) 2019, and then she had the right knee revised on (b)(6) 2023.The revision surgery was approximately 2 years, 7 months after initial implant.Revision operative report of (b)(6) 2023, for suspected polyethylene wear; right knee.The patient presented with painful knee.They were found to have progressive polyethylene wear as well as instability of the total knee.The patellar button was found to be intact but with some surface wear.The poly insert was removed and was noted to be intact with not gross damage.With removal of the femoral component there was noted adiacens be aori type 1 bone loss, not severe.The tibial component was grossly intact, not loose, it was removed with minimal bone loss.Bone loss of the tibial metaphysis warranted the use of a cone.The patellar component was removed, and the patella was resurfaced.Dressings were applied and the patient was transferred to the recovery room in stable condition.Patient was admitted (b)(6) 2023, and was discharged (b)(6) 2023.
Additional Manufacturer Narrative
H3: investigation results - the revision reported was likely the result of the patient¿s pain, joint instability, and assumed prosthesis wear.However, according to the revision operative notes, the tibial insert was ¿found to be intact with no gross damage.¿ the reported pain and instability may have been related to patient conditions and/or soft tissue laxity, but this cannot be confirmed from the information provided.The revised components were not returned to exactech for evaluation, and no radiographs or images were provided.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 2.5, 11MM
• 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 32563
• Manufacturer Contact: miguel sosa
• MDR Report Key: 16981298
• Report Number: 1038671-2023-01079
• Device Sequence Number: 20546185
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2026

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: 01/18/2026
• Device Model Number: 02-022-44-2511
• Device Catalogue Number: 02-022-44-2511
• Was Device Available for Evaluation?: No
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 09/19/2026
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 12/19/2023; 09/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2018
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female