MAUDE Adverse Event Report: EXACTECH, INC. ACTIVITE TRLNT CRC INSRT SIZE 1.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-024-51-1513
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 02-029-90-4300 - sterile packed short headed pin (b)(6), 201-78-88 - 4" drill bit, mod.Hex 2-pk (b)(6), 201-78-81 - 3" trocar, mod.Hex 2pk (b)(6), 201-78-81 - 3" trocar, mod.Hex 2pk (b)(6), 02-022-45-9999 - fit tray revision add, 02-020-13-0310 - truliant cr cem fem cr cem right sz 1 (b)(6), 02-022-45-1515 - truliant tib fit tray cem sz 1.5f / 1.5t (b)(6), 02-023-07-0029 - activite trlnt adv pat 29mm (b)(6).
Event or Problem Description
It was reported that this female patient's right knee was revised approximately 2 months post op.The patient was brought back for a right knee irrigation and debridement and poly swap.The poly liner was removed with the help of an osteotome.After irrigation and debridement was finished a new 1.5 13mm crc was implanted with 20cc intersep.Patient was last known to be in stable condition following the event.Product not returning: item was discarded.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, g.The reason for the reported revision cannot be confirmed from the information provided but may be due to wear, loosening, infection, fracture, instability, and/or patient related factors.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information, or radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: ACTIVITE TRLNT CRC INSRT SIZE 1.5, 13MM
• 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: 20241190
• Report Number: 1038671-2024-03570
• Device Sequence Number: 8090307
• Product Code: JWH
• UDI-Device Identifier: 10885862600714
• UDI-Public: 10885862600714
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/09/2025

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: 02-024-51-1513
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female