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

Model Number	TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated as it is not available.Concomitant medical products: 02-020-14-0335 - truliant cr por fem cr por right sz 3.5 sn: (b)(4), 02-022-55-3525 - truliant por tib tray size 3.5f/2.5t sn: (b)(4), 201-78-15 - holding pin mini sharp point 4 pk sn: (b)(4), 521-78-23 - threaded pin size 2.3 collared 2pk sn: (b)(4), 521-78-32 - threaded pin size 3.0 collarless 2pk 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 10042320077.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a female patient, initially implanted on the right knee on (b)(6) 2020, underwent a revision due to pain.The surgeon removed the insert and stated there was no significant poly wear.The articulation surface appeared smooth with no damage.The original insert was 9mm but the 10mm trial was found to be stable with good rom so a new 10mm crc was implanted.The surgeon also resurfaced the patella with a standard 35mm 3 peg patella and stated that the patient¿s pain was possibly from the patella.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H6: 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 cannot be conclusively determined; however, it is most likely related to the patient¿s condition.
Event or Problem Description
Additional information: no issues.Explants never available due to hospital policy".There were no reported issues with the revision surgical procedure.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, g2, h6: clinical code, medical device problem code, component code, type of investigation, investigation finding, investigation conclusion.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 cannot be conclusively determined; however, it is most likely related to the patient¿s condition.These devices are used for treatment not diagnosis.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: 15415003
• Report Number: 1038671-2022-01108
• Device Sequence Number: 12379555
• Product Code: JWH
• UDI-Device Identifier: 10885862307699
• UDI-Public: 10885862307699
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2026

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 3.5, 9MM
• Device Catalogue Number: 02-022-51-3509
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 12/17/2025
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/08/2022; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Female