MAUDE Adverse Event Report: EXACTECH, INC. ACTIVITE TRLNT PS INSRT SIZE 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER + ADD

Catalog Number	02-024-35-4009
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-020-11-0240 - truliant ps cem fem ps cem left sz 4: a972997.02-022-45-4040 - truliant tib fit tray cem sz 4f/4t: a543337.02-023-02-0035 - activite trlnt 3 peg pat 35mm: b424899.02-029-90-4300 - sterile packed short headed pin: b379348.203-96-64 - sawblades ez1913.M62 90x19, 1.27mm strkr5/6/7: 079471.521-78-23 - threaded pin size 2.3 collared 2pk: b386367.521-78-31 - threaded pin size 2.6 collarless 2pk: b378986.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 the patient underwent an initial total knee arthroplasty on the left side.Subsequently, the patient experienced instability.As a result, the surgeon did a poly swap and increased the poly thickness to a 4x11mm ps poly.Patient was last known to be in stable condition following the event.No further information available.

• Brand Name: ACTIVITE TRLNT PS INSRT SIZE 4, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER + ADD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24130000
• Report Number: 1038671-2026-00061
• Device Sequence Number: 5455831
• Product Code: OIY
• UDI-Device Identifier: 10885862597168
• UDI-Public: 10885862597168
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K223252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 01/21/2026

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: 02-024-35-4009
• 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: 12/30/2025
• Initial Report FDA Received Date: 01/21/2026
• Date Device Manufactured: 10/14/2024
• 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: 73 YR
• Patient Sex: Male