MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	TRULIANT TIB IMP PS INSERT SZ 2.5 15MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the 73 y/o male patient had a left knee replacement on (b)(6) 2020.Approximately 2 years and 10 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.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.Revision op report on (b)(6) 2022: diagnosis: septic arthritis left total knee arthroplasty.Pre-procedure: the patient developed left lower extremity cellulitis and knee pain.Aspiration of the knee was performed twice, second result notable for 41k nucleated cells.Procedure: purulent fluid erupted from joint space and was evacuated.Two deep culture swabs were obtained.The knee was irrigated with saline and betadine.A circumferential debridement was performed with anterior synovectomy.The polymer insert was removed.Debridement was continued with posterior synovectomy.Posterior synovium was sent as tissue specimen for culture.
Additional Manufacturer Narrative
D10: concomitants: 6381460, 02-012-60-1425 - tru stem ext 14mm x 25mm.6353015, 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5.4761748, 02-022-45-2535 - truliant tib fit tray cem sz 2.5f / 3.5t.6204867, 200-02-38 - three peg patella 38mm.6293189, 204-70-00 - tibial stem ext.Screw.11021019190, a10012 - gps implant kit v2.Pending investigation.
Event or Problem Description
The patient was admitted to the hospital with an uti.Surgical procedure 1) arthrotomy with drainage and anterior/posterior synovectomies infected knee 2) exchange of left knee polymer insert 3) application resorbable antibiotic bears left knee joint.Revised to exactech insert (3.5f/2.5t).He was taken to the recovery room in stable condition.No other information is available.
Additional Manufacturer Narrative
H10.Additional information ¿ b5, g2, h6 medical device problem code, h7, h8, h9 h6.Investigation results - truliant tib imp ps insert with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The polyethylene exchange is most likely related to the patient condition of septic arthritis and related to the uti, which caused a hospital admission.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, medical device problem code, component code, type of investigation.Manufacturer narrative updated: the reason for the revision reported may be the result of infection.The prosthesis wear and instability cannot be confirmed from the reported information and have been reported at this later time due to inclusion of the polyethylene in the packaging recall.Potential contributions of user to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2.5 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17308222
• Report Number: 1038671-2023-01626
• Device Sequence Number: 7213581
• Product Code: JWH
• UDI-Device Identifier: 10885862304223
• UDI-Public: 10885862304223
• 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: 2020
• 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): 11/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2025
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 2.5 15MM
• Device Catalogue Number: 02-022-35-2515
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 10/31/2024
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 01/10/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2017
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male