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

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Osteolysis (2377); Implant Pain (4561)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: cemented finned tib.Tra sz 3f/3t (cat# 200-04-33 / (b)(4)), logic cr femoral cem, right, sz 3 (cat# 02-010-03-0330 / (b)(4)), three peg patella 32mm (cat# 200-02-32 / (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 5.5 yrs postop the initial l tka this (b)(6) female 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
Section d1: brand name.Section d4: model number, catalog number, unique identifier (udi) #.Section d10: concomitant medical products.Section d10: concomitant medical products logic tib insert impl cr slope+, sz 4, 9mm (cat# 02-012-48-4009 / serial# (b)(6)).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)).
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt section d1: brand name section d4: model number, catalog number, unique identifier (udi) #.
Additional Manufacturer Narrative
(h3) 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.
Event or Problem Description
The patient experienced pain and impaired movement, and also underwent a bone graft during the revision surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6 component code.The following sections were corrected: h6 findings (4243 and 3211 removed), conclusions.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM
• 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
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13006052
• Report Number: 1038671-2021-00703
• Device Sequence Number: 20194239
• Product Code: JWH
• UDI-Device Identifier: 10885862174482
• UDI-Public: 10885862174482
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM
• Device Catalogue Number: 02-012-48-4009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 02/16/2022; 04/20/2022; 05/18/2022; 08/07/2024; 11/13/2024
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 02/19/2022; 05/04/2022; 06/09/2022; 09/03/2024; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2014
• 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 Age: 74 YR
• Patient Sex: Female