MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-022-35-2013
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement on (b)(6)2019.They underwent right knee revision on (b)(6)2022, approximately 3 years 2 months after their initial procedure.The patient clams to have a failed right total knee arthroplasty with contracture and severe pain.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.D10.Concomitants: (b)(6), 02-020-12-0320 - truliant ps por fem ps por right sz 2; (b)(6), 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t; (b)(6), 200-02-29 - three peg patella 29mm.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical 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.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.Additionally, this device was packaged after initiation of the recall and was not packaged in a non-conforming vacuum bag.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2 13MM
• 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: geoff gannon ; 3523782617
• MDR Report Key: 17226866
• Report Number: 1038671-2023-01503
• Device Sequence Number: 6969729
• Product Code: JWH
• UDI-Device Identifier: 10885862304100
• UDI-Public: 10885862304100
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: 05/24/2026
• Device Model Number: 02-022-35-2013
• Device Catalogue Number: 02-022-35-2013
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown