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

Model Number	02-022-51-3009
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Medical products: 02-022-45-3030.6527151- truliant tib fit tray cem sz 3f / 3t, 02-020-13-0330, 6559961 - truliant cr cem fem cr cem right sz 3, 200-07-35, 6606291 - advanced patella 35mm 3 peg implant.
Event or Problem Description
As reported, this 70 year old, female patient had an initial right side tka on (b)(6) 2021.The patient was revised on (b)(6) 2022.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
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; no reason for revision was given.H7: z-0023-2022.
Additional Manufacturer Narrative
G3/g4: date was accidentally left off on follow-up #1.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following corrections have been made: b1, d1, d4 (remove all-suspect device unknown), g3(remove 501k-unknown, h4 (remove date-unknown, h6: clinical code, component codes.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 IMPLANTS
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15165557
• Report Number: 1038671-2022-00875
• Device Sequence Number: 4717374
• Product Code: JWH
• UDI-Device Identifier: 10885862307637
• UDI-Public: 10885862307637
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/06/2025

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 Model Number: 02-022-51-3009
• Device Catalogue Number: 02-022-51-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022; 09/06/2022; 10/01/2025
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/23/2022; 10/06/2022; 10/06/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female