MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA TRAPTRAY CEM SZ 5F/5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-41-5050
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/07/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, approximately 6 months post op the initial left tka, this (b)(6) male patient was revised due to tibial component loosening.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 02-012-35-5009, logic tibia ps mod insrt sz 5 9mm.
Additional Manufacturer Narrative
Section h10: (h3) event has been determined to be a duplicate of 1038671-2011-00040 / c2011-030.

• Brand Name: LOGIC TIBIA TRAPTRAY CEM SZ 5F/5T
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15029547
• Report Number: 1038671-2022-00795
• Device Sequence Number: 4714351
• Product Code: JWH
• UDI-Device Identifier: 10885862003263
• UDI-Public: 10885862003263
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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 Model Number: 02-012-41-5050
• Device Catalogue Number: 02-012-41-5050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White