MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-022-35-2509
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 5169891, 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5; 5060873, 02-022-45-2515 - truliant tib fit tray cem sz 2.5f / 1.5t; 5187466, 200-02-32 - three peg patella 32mm; 5261933, 204-34-02 - fluted stem extension 25l x 14 mm; 5175535, 204-70-00 - tibial stem ext.Screw.
Event or Problem Description
As reported via legal documentation, a patient had bilateral knee replacement on (b)(6) 2018.They underwent subsequent left knee revision surgery on (b)(6) 2023, approximately 5 years 3 months after their primary replacement.On (b)(6) 2023 op report postoperative diagnosis: left total knee revision instability of left knee.Intraoperative finding indicated that there was severe synovitis.The polyethylene liner appeared to have very minimal wear, but there was medial lateral instability throughout the range of motion.There was severe wear of the patellar component.Very minimal osteolysis was noted in the anterior femur just proximal to the intercondylar notch.The femoral component appeared to be well fixed.Patient was taken to the recovery room in satisfactory condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This has been discovered to be a duplicate case and will be closed; all new and additional information will be processed and reported in mfr # 1038671-2023-01403.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: michael crader ; 3523782617
• MDR Report Key: 17282835
• Report Number: 1038671-2023-01587
• Device Sequence Number: 3480526
• Product Code: JWH
• UDI-Device Identifier: 10885862304162
• UDI-Public: 10885862304162
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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?: No
• Device Expiration Date: 12/07/2025
• Device Model Number: 02-022-35-2509
• Device Catalogue Number: 02-022-35-2509
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male