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

Model Number	02-022-35-4009
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient underwent right knee replacement on (b)(6) 2018.They are scheduled to undergo right knee revision surgery on (b)(6) 2023, approximately 5 years 2 months after their initial procedure.Patient claims to have suffered and continues to suffer permanent and debilitating injures and damages, including but not limited to significant pain and discomfort, swelling, limited mobility, inability to bend or kneel, gait impairment, and other injuries presently undiagnosed, which all require ongoing medical care.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.Concomitants: 5060206 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t 5236205 02-020-11-0340 - truliant ps cem fem ps cem right sz 4 5293859 200-07-32 - advanced patella 32mm 3 peg implant 5320026 02-012-60-1425 - tru stem ext 14mm x 25mm 5330961 204-70-00 - tibial stem ext.Screw.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, health effect - impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 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: kate jacobson ; 3523782617
• MDR Report Key: 17256745
• Report Number: 1038671-2023-01533
• Device Sequence Number: 12276505
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 07/28/2025
• Device Model Number: 02-022-35-4009
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 10/09/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown