MAUDE Adverse Event Report: EXACTECH, INC. ACTIVITE TRLNT PS INSRT SIZE 2.5, 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-024-35-2510
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5, (b)(6), 02-022-45-2520 - truliant tray, cem sz 2.5f/2t, (b)(6).02-023-02-0032 - activite trlnt 3 peg pat 32mm, (b)(6).02-024-35-2510 - activite trlnt ps insrt size 2.5, 10mm (b)(6).02-029-90-4300 - sterile packed short headed pin, (b)(6).203-96-64 - sawblades ez1913.M62 90x19, 1.27mm strkr5/6/7, (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).H3: 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.
Event or Problem Description
It was reported that this patient's left knee was revised approximately 1 year 3 month post initial operation.Patient felt unstable so the surgeon increased poly thickness to 13mm.Patient was last known to be in stable condition following the event.

• Brand Name: ACTIVITE TRLNT PS INSRT SIZE 2.5, 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: 21573086
• Report Number: 1038671-2025-01540
• Device Sequence Number: 8751942
• Product Code: JWH
• UDI-Device Identifier: 10885862596901
• UDI-Public: 10885862596901
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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 Catalogue Number: 02-024-35-2510
• 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: 02/18/2025
• Initial Report FDA Received Date: 03/11/2025
• Date Device Manufactured: 09/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female