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

Catalog Number	02-024-51-3509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-020-14-0335 - truliant cr por fem cr por right sz 3.5.(b)(6), 02-022-55-3535 - truliant por tib tray size 3.5f/3.5t.(b)(6), 02-029-90-4300 - sterile packed short headed pin.(b)(6), 201-78-98 - 2 pk, schanz pin, 4mm x 130mm.(b)(6), 521-78-23 - threaded pin size 2.3 collared 2pk.(b)(6), 521-78-32 - threaded pin size 3.0 collarless 2pk.(b)(6), 521-78-32 - threaded pin size 3.0 collarless 2pk.(b)(6), a10012 - gps implant kit v2.
Event or Problem Description
It was reported that a patient, initial right knee implanted in (b)(6) 2024, underwent a revision procedure in (b)(6) 2024, approximately 4 months post the initial procedure.The patient developed soft tissue adhesions.The patient had a manipulation under anesthesia with no success.They then undertook a surgical approach to free up the adhesions and performed a poly exchange.Likely they were removing the poly to improve exposure and as it¿s single use had to replace with a new one.There doesn¿t appear to be any alleged defect with the device.There were no issues with the surgery.The rep will try to retrieve the device to return for analysis.A device image was provided.No further information.

• Brand Name: TRULIANT, ACTIVIT-E
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19954462
• Report Number: 1038671-2024-02764
• Device Sequence Number: 8839521
• Product Code: JWH
• UDI-Device Identifier: 10885862601032
• UDI-Public: 10885862601032
• 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
• Report Date (Section B): 08/09/2024

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 Catalogue Number: 02-024-51-3509
• 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: 07/26/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• 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: Unknown