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

Catalog Number	02-022-35-3509
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Arthrofibrosis (4885)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2021.Approximately 1 year after the initial procedure the patient had a right knee revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on 13 oct 2022 diagnosis: right knee failure from inflammatory response to nickel, mechanical alignment differing from native anatomic alignment limiting flexion and extension.At intra-operative inspection, the rind of scar tissue surrounding the implant was confirmed and complete synovectomy performed.The patient was removed to the recovery room in stable condition.
Additional Manufacturer Narrative
D10: concomitants: 6808699 02-020-11-0335 - truliant ps cem fem ps cem right sz 3.5 6866704 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t ab7316 13a2101 - cemex system fast genta 70g 6981243 200-02-35 - three peg patella 35mm s308739 521-78-31 - threaded pin size 2.6 collarless 2pk s308742 521-78-31 - threaded pin size 2.6 collarless 2pk pending investigation.
Additional Manufacturer Narrative
H3.Investigation results- the cause of the patient¿s range of motion, nickel allergy, 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.Metal sensitivity reactions or other allergic/histological reactions to implant materials and range of motion are mentioned in the ifu.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
There were no markers for infection.The patient showed evidence of nickel allergy confirmed by ltt testing.Exactech components aligned at 5 degree ir, 3 deg anteriorly sloped tibial.Corrected to 9 deg dfa, 0 deg posterio tibial slope.The patella was in excellent condition, there was no loosening of the femoral component.Inspection of the femur showed fibrous tissue/synovium ingrowth between the cement and the metal implant.The patient was removed to the recovery room in stable condition.There is no mention of device malfunction or wear in the revision operative report.The patient was revised to competitor devices.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d1/d4: suspect device unknown, d10: (b)(6) - 02-020-11-0335 - truliant ps cem fem ps cem right sz 3.5.(b)(6) - 02-022-35-3509 - truliant tib imp ps insert sz 3.5 9mm.(b)(6) - 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t.(b)(6) - 13a2101 - cemex system fast genta 70g.(b)(6) - 200-02-35 - three peg patella 35mm.(b)(6) - 521-78-31 - threaded pin size 2.6 collarless 2pk.(b)(6) - 521-78-31 - threaded pin size 2.6 collarless 2pk e1, g4/h4: suspect device unknown, h6: clinical code, medical device problem code, component code, type of investigation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT KNEE COMPONENTS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18463189
• Report Number: 1038671-2024-00028
• Device Sequence Number: 11538366
• Product Code: JWH
• UDI-Device Identifier: 10885862304346
• UDI-Public: 10885862304346
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• 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): 10/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-35-3509
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 03/12/2024; 10/29/2025
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 03/12/2024; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown