MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3.5, 10MM; SEE H10

Model Number	02-022-44-3510
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitant medical products: 6570141, 02-012-60-1425 - logic stem ext 14mm x 25mm.5394043, 02-020-11-0235 - truliant ps cem fem ps cem left sz 3.5.6531093, 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t.6528382, 200-02-35 - three peg patella 35mm.6663882, 201-78-15 - holding pin mini sharp point 4 pk.6635678, 201-78-98 - 2 pk, schanz pin, 4mm x 130mm.6638802, 201-78-98 - 2 pk, schanz pin, 4mm x 130mm.6515059, 204-70-00 - tibial stem ext.Screw.S103686, 521-78-23 - threaded pin size 2.3 collared 2pk.S101360, 521-78-32 - threaded pin size 3.0 collarless 2pk.S101383, 521-78-32 - threaded pin size 3.0 collarless 2pk.H6.Investigation: the tibial insert, serial number (b)(6), is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's revision surgery as related to the devices cannot be conclusively determined, insufficient information.The patient has bilateral knee replacements.These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported via legal documentation that this patient had an initial left knee arthroplasty (b)(6) 2020 and then approximately 1 year, 10 months, later on (b)(6) 2022 had a revision surgery for an unreported reason.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
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or 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 PSC INSERT SZ 3.5, 10MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon
• MDR Report Key: 16956880
• Report Number: 1038671-2023-01038
• Device Sequence Number: 15182418
• Product Code: JWH
• UDI-Device Identifier: 10885862305176
• UDI-Public: 10885862305176
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 01/24/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2026
• Device Model Number: 02-022-44-3510
• Device Catalogue Number: 02-022-44-3510
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female