MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	TRULIANT TIB IMP PS INSERT SZ 5 12MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint effusion (4849)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male patient, who was initially implanted on the left knee on (b)(6) 2018, was seen in the clinic and they are having symptoms/pain/effusions, indicating a revision surgery is necessary.A revision ltka has been scheduled for (b)(6) 2022.No other patient information reported.
Additional Manufacturer Narrative
Device return not anticipated at this time as it remains implanted.Concomitant medical products: 02-020-11-0250, 5131454 - truliant ps cem fem ps cem left sz 5; 02-022-45-5050, 5428300 - truliant tib fit tray cem sz 5f / 5t; 200-02-41, 5243033 - three peg patella 41mm; 201-78-18, 5261857 - holding pin headless no ribs w/30 deg pt 4 pack.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
H6: 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 pain and subsequent planned revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
H6.Investigation results for prosthesis wear - the revision reported may have been the result of femoral loosening, osteolysis, and prosthesis wear as stated in the provided information.However, this cannot be confirmed as the device(s),images of the device/ pre-revision radiographs, and operative notes were not available for evaluation.These devices are used for treatment not diagnosis.Correction h7 & h9 - this device is not part of a recall.
Additional Manufacturer Narrative
Additional information: a2, b1, b5, b7, h6: health effect - clinical code.Corrected information: b3, h6: health effect - impact code, medical device problem code.
Event or Problem Description
Pre-op/post-op diagnoses: failed left tka secondary to aseptic femoral loosening.Indications: increasing effusions and weightbearing pain with clinical evidence of a femoral loosening.Procedure: the patella was well fixed, left in place.Previous 12 mm insert was removed.The femoral was disimpacted from intact cement mantle.Tibia was well fixed, left in place.Previous 12mm insert was removed.The femoral was disimpacted.Tibia was well fixed and left in place.The patient was revised to exactech devices.No complications.Patient was taken to recovery in stable condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported in cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening 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.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 5 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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 ; 3523771140
• MDR Report Key: 15439148
• Report Number: 1038671-2022-01134
• Device Sequence Number: 6005137
• Product Code: JWH
• UDI-Device Identifier: 10885862304643
• UDI-Public: 10885862304643
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/22/2025

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: 09/07/2025
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 5 12MM
• Device Catalogue Number: 02-022-35-5012
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 05/26/2023; 10/08/2024; 04/21/2025
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/10/2022; 05/31/2023; 10/14/2024; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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: 65 YR
• Patient Sex: Male