MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP CRC INSERT SZ 5, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Implant Pain (4561)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5668016 02-020-13-0250 - truliant cr cem fem cr cem left sz 5.5527540 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t.5586943 200-02-38 - three peg patella 38mm.5758114 201-78-15 - holding pin mini sharp point 4 pk.S009495 521-78-23 - threaded pin size 2.3 collared 2pk.S009967 521-78-31 - threaded pin size 2.6 collarless 2pk.S009989 521-78-31 - threaded pin size 2.6 collarless 2pk.S004738 521-78-36 - threaded pin size 5.1 collarless 2pk.S004875 521-78-36 - threaded pin size 5.1 collarless 2pk.S004876 521-78-36 - threaded pin size 5.1 collarless 2pk.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 for pain cannot be conclusively determined; however, it is most likely related to patient related conditions.
Event or Problem Description
It was reported that a male patient, had an initial left knee implanted on (b)(6) 2019, and underwent a revision procedure on (b)(6) 2022, approximately 3 years 9 months post the initial procedure.The patient presented with pain and synovitis.A new 9mm crc insert was implanted and had good range of motion and stability after some releases were performed.There were no reported issues during the revision surgical procedure.Minimal wear was noted by the surgeon.The patient left in stable condition.Explants are not available for return.No further information is available from the representative.
Additional Manufacturer Narrative
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 relevant clinical information 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 corrected information.The following sections were corrected: b2, h6 - investigation findings, investigation conclusion, h7 (remove information) and h9 (remove information).If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT
• 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 ; 3523771140
• MDR Report Key: 15777542
• Report Number: 1038671-2022-01452
• Device Sequence Number: 11980394
• Product Code: JWH
• UDI-Device Identifier: 10885862307873
• UDI-Public: 10885862307873
• 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
• 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
• Report Date (Section B): 04/22/2026

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: 09/24/2026
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 5, 9MM
• Device Catalogue Number: 02-022-51-5009
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: Not provided; 04/21/2026
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/18/2024; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2018
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male