MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 5, 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-5017
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 70 months after a right total knee replacement procedure, the patient experienced prosthesis wear, joint pain, swelling and stiffness.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 02-012-60-1616 - tru stem ext 16mm x 160mm.(b)(6) 02-012-61-2000 - tru offset stem ext coupler, 2mm.(b)(6) 02-012-42-5008 - logic pts, size 5, 8mm.(b)(6) 02-012-61-2000 - tru offset stem ext coupler, 2mm.(b)(6) 02-012-60-1416 - tru stem ext 14mm x 160mm.5042500208-06-05 - cc distal fem augment sz 5, 10mm.(b)(6) 208-05-05 - cc distal fem augment sz 5, 5mm.(b)(6) 02-010-06-0350 - tru cc femoral size 5 right.(5374497)02-010-06-0551 - tru post.Aug.Size 5, 5mm.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
B1: updated.B2: updated.H6: corrected health effect - clinical code, type of investigation.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.

• Brand Name: LOGIC CC TIB INSERT SIZE 5, 17MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19655644
• Report Number: 1038671-2024-02255
• Device Sequence Number: 6540503
• Product Code: JWH
• UDI-Device Identifier: 10885862266262
• UDI-Public: 10885862266262
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 03/28/2026
• Device Catalogue Number: 02-012-65-5017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown