MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-4009
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5.5 yrs postop the initial l tka this patient was scheduled for a revision due to increase wear.During surgery we noticed that the insert was moving within the tibial tray.The poly was removed and a new size 4 / 9mm neutral was inserted and still had the same issue the poly appeared not to be locking into the tibial tray.Patient was last known to be in stable condition following the event.Devices are expected to be returned for evaluation.
Additional Manufacturer Narrative
Product has been received by exactech and the investigation is complete - see details below.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2021-00703.The revision reported was likely the result of third body wear, instability, patient-related conditions, or any combination of these possibilities, which led to polyethylene wear.The reported movement of the in-situ tibial insert in the tibial tray may have been the result of the worn locking mushroom and tibial insert subsidence in the tibial tray.The reported intra-operative seating difficulty may have been the result of incomplete/off-axis insertion of the tibial insert into the tibial tray, which may have allowed motion of the tibial insert in the tibial tray.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.Furthermore, the most probable root cause associated with the reported event of "assembly/seating difficulty¿ is associated with assembling or seating a polyethylene component during implantation.(d10) concomitant medical products: optetrak tibial tray cem sz 4f / 4t (cat# 200-04-44 / serial# (b)(6)); femoral component cr, cemented size 4 (cat# 02-010-04-0340 / serial# (b)(6)); optetrak 3 peg patella cem, 38mm (cat# 200-02-38 / serial# (b)(6)).If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 4, 9MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20820481
• Report Number: 1038671-2024-04554
• Device Sequence Number: 18051576
• Product Code: JWH
• UDI-Device Identifier: 10885862174444
• UDI-Public: 10885862174444
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: 02-012-47-4009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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: Hospitalization
• Patient Sex: Female