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

Model Number	TRULIANT TIB IMP PSC INSERT SZ 4, 11MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 60 yo male patient, initial right knee implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2022, approximately 2 years 3 months post the initial procedure.The patient presented with pain, stiffness and synovitis.He was revised from an 11mm psc insert to a 9mm crc with good rom and stability.The insert had no visual damage except for what incurred from using the osteotome for removal.Patient was last known to be in stable condition.The explants are not available for return.
Additional Manufacturer Narrative
Concomitant medical products: 6214432, 02-020-11-0340, truliant ps cem fem ps cem right sz 4, 6455538, 02-022-45-4040, truliant tib fit tray cem sz 4f / 4t, 6436356, 200-02-38, three peg patella 38mm, 6494320, 201-78-15, holding pin mini sharp point 4 pk, s042345, 521-78-23, threaded pin size 2.3 collared 2pk, s064280, 521-78-23, threaded pin size 2.3 collared 2pk, s049576, 521-78-32, threaded pin size 3.0 collarless 2pk, s051317, 521-78-32, threaded pin size 3.0 collarless 2pk, s039400, 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 pain and subsequent revision cannot be conclusively determined; however, it is most likely patient-related conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and/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.

• 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: 15777477
• Report Number: 1038671-2022-01443
• Device Sequence Number: 20518434
• Product Code: JWH
• UDI-Device Identifier: 10885862305282
• UDI-Public: 10885862305282
• 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: 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): 02/26/2025

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: 01/03/2026
• Device Model Number: TRULIANT TIB IMP PSC INSERT SZ 4, 11MM
• Device Catalogue Number: 02-022-44-4011
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• 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: 60 YR
• Patient Sex: Male