MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 2.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PSC INSERT SZ 2.5, 11MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this patient had a initial right tka on (b)(6) 2022.The patient presented with an infected knee and the poly was exchanged during an i&d procedure.A new poly was implanted.The patient was last known to be in stable condition following the event.The device is not returning as it is against hospital policy.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-012-60-1425 - logic stem ext 14mm x 25mm sn: (b)(4), 02-020-11-0325 - truliant ps cem fem ps cem right sz 2.5 sn: (b)(4), 02-022-45-2520 - truliant tray, cem sz 2.5f/2t sn: (b)(4), 200-07-29 - advanced patella 29m 3 peg implant sn: (b)(4), 201-78-15 - holding pin mini sharp point 4 pk sn: (b)(4), 204-70-00 - tibial stem ext.Screw sn: (b)(4), 521-78-23 - threaded pin size 2.3 collared 2pk sn: (b)(4), sn: (b)(4), 521-78-32 - threaded pin size 3.0 collarless 2pk sn: (b)(4), 521-78-36 - threaded pin size 5.1 collarless 2pk sn: (b)(4), a10012 - gps implant kit v2 sn: (b)(4).
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision for infection cannot be conclusively determined, patient conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: a4.The following sections were corrected: a2, d1, remove information from d4, remove information from g4, remove information from h4, h6.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: b, c, d, g.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.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 following sections were updated/corrected: h6 mdr section codes updated/corrected: e the reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.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 2.5, 11MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15390482
• Report Number: 1038671-2022-01067
• Device Sequence Number: 5402731
• Product Code: JWH
• UDI-Device Identifier: 10885862305008
• UDI-Public: 10885862305008
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/06/2025

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 Model Number: TRULIANT TIB IMP PSC INSERT SZ 2.5, 11MM
• Device Catalogue Number: 02-022-44-2511
• 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: 08/20/2022
• Supplement Date Received by Manufacturer: 02/08/2023; Not provided; 08/08/2025; 10/03/2025
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 02/08/2023; 07/29/2025; 08/11/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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 Age: 86 YR
• Patient Sex: Female
• Patient Weight: 80 KG