MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Implant Pain (4561)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 02-020-14-0345 - truliant cr por fem cr por right sz 4.5, 6724408, 02-022-55-4545 - truliant por tib tray size 4.5f/4.5t, 6869625, 201-78-15 - holding pin mini sharp point 4 pk, 6891722, 521-78-23 - threaded pin size 2.3 collared 2pk, s045140, 521-78-32 - threaded pin size 3.0 collarless 2pk, 5440117, s265331, 521-78-36 - threaded pin size 5.1 collarless 2pk, s223293.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported a male patient, initial right knee implanted on (b)(6) 2021, underwent a revision procedure on (b)(6) 2022, approximately 1 year 3 months post the initial procedure due to paint and synovitis.Some moderate wear was noted per surgeon.The knee was a little tight in flexion, so releases were performed and a thinner size 9mm insert was used with good rom and stability.The patient left in stable condition.Explant not available.No further information.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: the reason for the pain and synovitis leading to the revision reported cannot be determined from the information provided, but does not appear to be related to prosthesis wear as the provided images do not show signs of wear that are inconsistent with an implanted device.Contributing factors to the revision may have been high tension of the joint during flexion and inclusion of the implanted polyethylene component in the packaging recall.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, h6: clinical code, component code, type of investigation, investigation findings, investigation conclusions.The reason for the pain and synovitis leading to the revision reported cannot be determined from the information provided but does not appear to be related to prosthesis wear as the provided images do not show signs of wear that are inconsistent with an implanted device.Contributing factors to the revision may have been high tension of the joint during flexion and inclusion of the implanted polyethylene component in the packaging recall.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported a male patient had an initial right knee implanted and then underwent a revision procedure, approximately 1 year 3 months post the initial procedure due to paint and synovitis.Some moderate wear was noted per surgeon.The knee was a little tight in flexion, so releases were performed and a thinner size 9mm insert was used with good rom and stability.The patient left in stable condition.Explant not available.No further information.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM
• 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 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 15923022
• Report Number: 1038671-2022-01569
• Device Sequence Number: 14754658
• Product Code: JWH
• UDI-Device Identifier: 10885862312679
• UDI-Public: 10885862312679
• 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: 2021
• 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): 02/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM
• Device Catalogue Number: 02-022-51-4510
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 04/14/2023; 02/20/2026
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 05/08/2023; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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; Hospitalization
• Patient Sex: Male