MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.D10.Concomitants - product information: 6524032 02-012-64-1812 - tru fluted stm ext 18mm x120mm blast; 6675526 02-010-06-0340 - tru cc femoral size 4 right; 7042642 208-05-04 - cc distal fem augment sz 4, 5mm pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had an initial right total knee arthroplasty on (b)(6) 2022, with no revision surgery reported.There was no other patient/medical information provided.No x-rays or images were provided.There is no other information available.
Additional Manufacturer Narrative
H11.Updated/additional information ¿ g1.G2.G4.H6.The reason for the patient¿s reported pain, stiffness, and weakness cannot be determined from the information provided but may be related to the patient¿s underlying condition and activity.The prosthesis wear alleged cannot be confirmed as the devices remain implanted and no clinical information was available at the time of evaluation.Additionally, the reported tibial insert is not involved in the packaging recall.
Additional Manufacturer Narrative
The reason for the patient¿s reported pain, stiffness, and weakness cannot be determined from the information provided but may be related to the patient¿s underlying condition and activity.The prosthesis wear alleged cannot be confirmed as the devices remain implanted and no clinical information was available at the time of evaluation.Additionally, the reported tibial insert is not involved in the packaging recall.H6: corrected health effect, component, and investigation clinical codes.
Additional Manufacturer Narrative
H6: corrected health effect - impact code.The reason for the patient¿s reported pain, stiffness, and weakness cannot be determined from the information provided but may be related to the patient¿s underlying condition and activity.The prosthesis wear alleged in incident cannot be confirmed as the devices remain implanted and no clinical information was available at the time of evaluation.Additionally, the reported tibial insert is not involved in the packaging recall.

• Brand Name: LOGIC CC TIB INSERT SIZE 4, 11MM
• 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 INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 18934571
• Report Number: 1038671-2024-00567
• Device Sequence Number: 9364379
• Product Code: JWH
• UDI-Device Identifier: 10885862266118
• UDI-Public: 10885862266118
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2024

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 Expiration Date: 04/28/2024
• Device Catalogue Number: 02-012-65-4011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 05/13/2024; 11/13/2024; 11/12/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/05/2024; 11/13/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2016
• 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 Sex: Unknown