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

Model Number	TRULIANT TIB IMP CRC INSERT SZ 3, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint effusion (4849)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated as they are not released without consent.Concomitants medical devices: 02-012-60-1425 - logic stem ext 14mm x 25mm 6588058, 02-020-13-0330 - truliant cr cem fem cr cem right sz 3 5861569, 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t 6666423, 200-02-35 - three peg patella 35mm 6560355, 201-78-15 - holding pin mini sharp point 4 pk 6684556, 201-78-98 - 2 pk, schanz pin, 4mm x 130mm 6737479, 204-70-00 - tibial stem ext.Screw 6580228, 521-78-23 - threaded pin size 2.3 collared 2pk s128891, 521-78-32 - threaded pin size 3.0 collarless 2pk s092681, s092682, a10012 - gps implant kit v2 09019020060.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, initial right knee implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2022, approximately 1 year 9 months post the initial procedure due to pain.The surgeon performed releases and went up to an 11mm insert with good rom and stability.He noted mild synovitis and poly wear.The damage of the insert was from using osteotome to remove it.Patient left in stable condition.The device is not returning as it is standard procedure to not release explants without patient consent.No further information available.
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 may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.
Additional Manufacturer Narrative
Having received additional information, the following fields have been updated: a2, g3, h6.Supplemental information and/or investigation findings will be reported within 30 days of receipt.
Additional Manufacturer Narrative
H6.Investigation conclusion for pain: the truliant device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.No additional information.
Event or Problem Description
Revision operative report of (b)(6) 2022.Diagnoses painful right knee arthroplasty with right polyethylene liner exchange.Intraoperative findings: synovitis was appreciated, and a partial synovectomy was performed.Polyethylene liner was removed.There was no catastrophic wear along the polyethylene liner.A medical soft tissue release and a larger exactech poly liner was implanted.The patella tracked well.Follow up with orthopedic clinic 2 weeks post op for wound check and staple removal.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6: health effect clinical code, component code, type of investigation and investigation findings.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11.No device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.A review of complaint history determined that no further action is required as no trends were identified.The revision reported was likely the result of pain and/or due to inclusion of the patient¿s polyethylene component in the packaging recall.However, this cannot be confirmed as the devices were not returned for evaluation, images of the other components were not provided, and additional patient history was not provided.Additionally, wear was noted on the tibial insert in the provided image, which may have contributed to the reported pain; however, the relationship between the insert wear and the patient¿s pain cannot be confirmed should additional relevant information be obtained, a follow-up mdr will be submitted 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: 15642702
• Report Number: 1038671-2022-01340
• Device Sequence Number: 15047174
• Product Code: JWH
• UDI-Device Identifier: 10885862307637
• UDI-Public: 10885862307637
• 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: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/03/2026

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 Model Number: TRULIANT TIB IMP CRC INSERT SZ 3, 9MM
• Device Catalogue Number: 02-022-51-3009
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 04/18/2023; 05/30/2023; 02/14/2026; 04/01/2026
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/10/2022; 05/15/2023; 05/30/2023; 02/21/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female