MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC TIBIA PS MOD INSRT TRIAL SZ 2.5 9MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 62 yo female patient, initial left knee implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2022, approximately 3 years 9 months post the initial procedure due to complaints of stiffness in their knee.During the procedure, the trial logic poly was removed using the logic style poly handle and once removed it was shown that the poly trial had broken on the underside.The surgeon used a rongure to remove the broken poly trial piece from the tibial tray and wound.The knee joint and surrounding wound was irrigated well.The new 9mm ps poly implant for the sz 2.5 was implanted into the knee and a final rom was performed.The surgeon was satisfied.There was a surgical delay while removing the parts and pieces from the wound site with no adverse event to the patient.The patient left the or stable.The device is available for return.The revision procedure is reported under report #1038671-2022-01327.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: based on historical complaint investigations, the returned device, and the reported event, the fractured logic ps tibial insert trial reported may have been the result of years of surgical use, aggressive use, and subsequent sterilization cycles which led to crack initiation, propagation, and ultimate fracture of the device during trialing.

• Brand Name: LOGIC
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• 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: kate jacobson ; 3523771140
• MDR Report Key: 15629245
• Report Number: 1038671-2022-01328
• Device Sequence Number: 20283076
• Product Code: JWH
• UDI-Device Identifier: 10885862004215
• UDI-Public: 10885862004215
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 07/09/2026

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 Model Number: LOGIC TIBIA PS MOD INSRT TRIAL SZ 2.5 9MM
• Device Catalogue Number: 02-013-35-2509
• Device Lot Number: 12160792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 03/06/2023; 07/09/2026
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 03/21/2023; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female