MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP PS INSERT SZ 3 10MM
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); Synovitis (2094)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, male patient underwent bi-lateral knee replacement on or about (b)(6) 2019.The surgeon used trulliant tibial inserts for both knee replacements.These products were manufactured by exactech inc.And have since been recalled by exactech.Following the initial operations, patient has suffered injuries and damages due to the defective products, including but not limited to, additional surgical interventions.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, d10, g3, g4, g6, h2, h3, h4, h6 and h9 have been updated accordingly.Section d10: concomitant medical products: truliant ps cem fem ps cem left sz 3 (cat# 02-020-11-0230 / serial# (b)(6)).Truliant tib fit tray cem sz 3f / 3t (cat# 02-022-45-3030 / serial# (b)(6)).Three peg patella 35mm (cat# 200-02-35 / serial# (b)(6)).(h3) as reported by the legal brief, male patient underwent bi-lateral knee replacement on or about (b)(6), 2019.The surgeon used trulliant tibial inserts for both knee replacements.These products were manufactured by exactech inc.And have since been recalled by exactech.Following the initial operations, patient has suffered injuries and damages due to the defective products, including but not limited to, additional surgical interventions on his left knee.No additional information available.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; reason not reported.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
As a result of additional information provided, the following fields have been updated: a2, b3, b5, b7, d6b, d8, and h6.Additional information and/or re-opened investigation findings will be provided within 30 days of receipt.See h10.
Event or Problem Description
As reported via legal documentation, a patient had primary left knee replacement surgery on (b)(6) 2019.They underwent left knee revision surgery on (b)(6) 2023, approximately 3 years, 2 months post primary procedure.(b)(6) 2023 op report noted there was a moderate amount of synovitis, and that the liner had wear in the medial compartment.The femur and tibia were noted to not have any bony defects or osteolysis, and the patella was in place without loosening or osteolysis as well.The patient tolerated the procedure well and left the operating room in good condition.
Additional Manufacturer Narrative
H6: corrected health effect - clinical code, component code, type of investigation, and investigation conclusions.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.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3 10MM
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14781790
• Report Number: 1038671-2022-00711
• Device Sequence Number: 14921889
• Product Code: JWH
• UDI-Device Identifier: 10885862304261
• UDI-Public: 10885862304261
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/08/2024

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: 01/10/2026
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 3 10MM
• Device Catalogue Number: 02-022-35-3010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 08/24/2022; 11/07/2024
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 09/24/2022; 08/22/2023; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male