MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT CR POR FEM CR POR LEFT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-022-51-3510
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 6657637, 02-020-14-0235 - truliant cr por fem cr por left sz 3.5, 6667564, 02-022-55-3525 - truliant por tib tray size 3.5f/2.5t, 6673602, 200-07-32 - advanced patella 32mm 3 peg implant, 5292282, 201-78-15 - holding pin mini sharp point 4 pk.
Event or Problem Description
As reported, approximately 1.5 years post op the initial left tka, this 37 y/o male patient was revised due to the bone never grew into the porous components.The porous components were revised to cemented components.Patient was last known to be in stable condition following the event.Devices will not be retuning, hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) 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 patient conditions.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, approximately 1.5 years post op the initial left tka, this 37 y/o male patient was revised due to the bone never grew into the porous components.The porous components were revised to cemented components.Patient was last known to be in stable condition following the event.Devices will not be retuning, hospital policy.No other information.
Event or Problem Description
As reported, approximately 1.5 years post op the initial left tka, this 37 y/o male patient was revised due to the bone never grew into the porous components.The porous components were revised to cemented components.Patient was last known to be in stable condition following the event.Devices will not be retuning, hospital policy.No other information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4, d8, g4, h4, h6: clinical code medical device problem code, component code, type of investigation and investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT CR POR FEM CR POR LEFT SZ 3.5
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15454650
• Report Number: 1038671-2022-01140
• Device Sequence Number: 6842584
• Product Code: JWH
• UDI-Device Identifier: 10885862315014
• UDI-Public: 10885862315014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• 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,Followup
• Report Date (Section B): 07/08/2026

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: 02-022-51-3510
• Device Catalogue Number: 02-020-14-0235
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 02/11/2026; 07/07/2026
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 09/30/2022; 03/02/2026; 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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: A
• 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: Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female