MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CR INS STD SZ 2, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint effusion (4849)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief indicates that on (b)(6) 2019 patient underwent a left total knee replacement surgery and was implanted with an optetrak device, including an insert made of polyethylene.Patient underwent revision surgery of her left knee on (b)(6) 2022.As a direct, proximate and legal consequence of the defective nature of the optetrak device, patient has suffered and continues to suffer permanent and debilitating injuries and damages, including but not limited to, significant pain and discomfort, gait impairment, poor balance, difficulty walking, component part loosening, soft tissue damage, bone loss, and other injuries presently undiagnosed, which require ongoing medical care.
Additional Manufacturer Narrative
Concomitant products: truliant cr cem fem cr cem left sz 2 (cat# 02-020-13-0220 / serial# (b)(4)).Truliant tib fit tray cem sz 2f / 2t (cat# 02-022-45-2020 / serial# (b)(4)).Three peg patella 29mm (cat# 200-02-29 / serial# (b)(4)).Holding pin mini sharp point 4 pk (cat# 201-78-15 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6.Investigation - based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, e.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.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0023-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.
Event or Problem Description
It was reported via legal documentation that approximately 50 months after a left total knee replacement procedure, the patient has experienced prosthesis wear, pain and effusions.Initial surgery and revision surgery operative notes were provided.Post operative diagnosis noted wear of the implant.Intraoperatively the surgeon observed an effusion which was non-purulent and no metallosis present.It was noted the polyethylene insert showed beginning signs of discoloration and a small amount of wear about the lip of the insert.A new insert was implanted and noted to be satisfactorily to full extension and flexion.No surgical or medical interventions were reported.No additional information is available.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 2, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16311479
• Report Number: 1038671-2023-00111
• Device Sequence Number: 7049244
• Product Code: JWH
• UDI-Device Identifier: 10885862306272
• UDI-Public: 10885862306272
• 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: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/18/2025

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: 01/11/2026
• Device Model Number: TRULIANT TIB IMP CR INS STD SZ 2, 9MM
• Device Catalogue Number: 02-022-47-2009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 11/08/2023; 04/17/2025
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 04/24/2023; 03/03/2025; 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2018
• 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
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female