MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 2, 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-2010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.D10 concomitants: (b)(6) 02-020-13-0220 - truliant cr cem fem cr cem left sz 2 (b)(6) 02-020-13-0320 - truliant cr cem fem cr cem right sz 2 (b)(6) 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t (b)(6) 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t (b)(6) 02-022-51-2010 - truliant tib imp crc insert sz 2, 10mm (b)(6) 200-02-29 - three peg patella 29mm (b)(6) 200-02-29 - three peg patella 29mm (b)(6) 201-78-15 - holding pin mini sharp point 4 pk (b)(6) 521-78-23 - threaded pin size 2.3 collared 2pk (b)(6) 521-78-31 - threaded pin size 2.6 collarless 2pk.(b)(6) 521-78-31 - threaded pin size 2.6 collarless 2pk.
Event or Problem Description
It was reported that this patient's left knee was revised approximately 7 years post initial operation.Patient was revised due to the recall.
Additional Manufacturer Narrative
H6: corrected component and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 2, 10MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21403704
• Report Number: 1038671-2025-01007
• Device Sequence Number: 8214740
• Product Code: JWH
• UDI-Device Identifier: 10885862312525
• UDI-Public: 10885862312525
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2025
• Device Catalogue Number: 02-022-51-2010
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 08/01/2025
• Date Device Manufactured: 09/07/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female