MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-022-47-4013
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Arthrofibrosis (4885)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this male patient's left knee was revised approximately 2 years post op due to premature polyethylene wear of the tibial insert.No other information available.
Additional Manufacturer Narrative
Concomitant device(s): 02-020-13-0240 - truliant cr cem fem cr cem left sz 4 6519329, 02-022-45-4050 - truliant tib fit tray cem sz 4f / 5t 5954886, 200-02-35 - three peg patella 35 mm 6003772.
Additional Manufacturer Narrative
Section h10: (h3) the reported revision may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.However, this cannot be confirmed.Additionally, a contributing factor to the reported polyethylene failure may have been the result of being packaged in a non-conforming vacuum bag for more than five years.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of prosthesis wear as stated in the legal documentation.Possible reasons for the tibial insert wear include malalignment between the femoral and tibial components, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the device was not available for evaluation and images of the explanted devices and pre-revision radiographs 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 this male patient underwent revision of the left knee approximately 2 years postoperatively due to suspected premature polyethylene wear of the tibial insert.No additional information was provided.During the procedure, heavy scar tissue was observed and debrided from the suprapatellar pouch and the medial and lateral gutters.The polyethylene insert was removed and inspected.Examination revealed pitting on the medial and lateral joint surfaces and mild abrasion along the eminence portion, consistent with wear.The patient was taken to recovery room in stable condition.No further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: a2, b1, h6.The following sections were corrected: a1, b2, b5, h6.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 4, 13MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15546476
• Report Number: 1038671-2022-01252
• Device Sequence Number: 17767641
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2026

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: 05/20/2025
• Device Model Number: 02-022-47-4013
• Device Catalogue Number: 02-022-47-4013
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 12/13/2024; 04/21/2026
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/09/2022; 12/13/2024; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male